{"id":438,"date":"2025-08-27T16:13:51","date_gmt":"2025-08-27T08:13:51","guid":{"rendered":"https:\/\/www.fda-registered.com\/?p=438"},"modified":"2025-08-27T16:13:53","modified_gmt":"2025-08-27T08:13:53","slug":"fda-510k-exemption-registration-services","status":"publish","type":"post","link":"https:\/\/www.fda-registered.com\/en\/fda-510k-exemption-registration-services\/","title":{"rendered":"FDA 510(k) \u8c41\u514d\u6ce8\u518c\u5168\u6d41\u7a0b\u89e3\u6790"},"content":{"rendered":"<h3 class=\"wp-block-heading\">FDA 510(k) \u8c41\u514d\u6ce8\u518c\u6982\u8ff0<\/h3>\n\n\n\n<p>FDA \u89c4\u5b9a\uff0c\u5927\u591a\u6570\u533b\u7597\u5668\u68b0\u5728\u7f8e\u56fd\u5e02\u573a\u4e0a\u5e02\u524d\u9700\u63d0\u4ea4 510(k) \u7533\u8bf7\uff0c\u4f46\u90e8\u5206\u4f4e\u98ce\u9669 Class I \u53ca\u5c11\u91cf Class II \u4ea7\u54c1\u53ef\u83b7\u5f97 <strong>510(k)\u8c41\u514d<\/strong>\u3002\u8c41\u514d\u4ea7\u54c1\u4ecd\u9700\u5b8c\u6210\u6ce8\u518c\u3001\u5217\u540d\u3001\u9075\u5faa\u8d28\u91cf\u4f53\u7cfb\uff08QSR\uff09\u4ee5\u53ca\u6807\u7b7e\u4e0e UDI \u8981\u6c42\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u6ce8\u610f\uff1a\u8c41\u514d\u4ec5\u514d\u9664 510(k) \u5ba1\u6838\uff0c\u4e0d\u7b49\u540c\u4e8e\u514d\u9664\u5408\u89c4\u4e49\u52a1\u3002<\/p>\n<\/blockquote>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">1. \u9002\u7528\u4ea7\u54c1\u8303\u56f4<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class I \u533b\u7597\u5668\u68b0<\/strong>\uff08\u5982\u624b\u672f\u526a\u5200\u3001\u538b\u820c\u677f\u3001\u4e34\u5e8a\u6e29\u5ea6\u8ba1\u7b49\uff09\uff0c\u901a\u5e38\u8c41\u514d 510(k)\u3002<\/li>\n\n\n\n<li><strong>\u90e8\u5206 Class II \u533b\u7597\u5668\u68b0<\/strong>\uff0cFDA\u660e\u786e\u8c41\u514d\u53ef\u514d\u63d0\u4ea4\u3002<\/li>\n\n\n\n<li><strong>\u9650\u5236\u6761\u6b3e<\/strong>\uff1a\u7528\u9014\u6216\u89c4\u683c\u8d85\u51fa FDA \u5b9a\u4e49\u4ecd\u9700\u63d0\u4ea4 510(k)\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">2. \u5168\u6d41\u7a0b\u89e3\u6790<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>\u6b65\u9aa4<\/th><th>\u63cf\u8ff0<\/th><\/tr><\/thead><tbody><tr><td><strong>1. \u786e\u8ba4\u8c41\u514d\u72b6\u6001<\/strong><\/td><td>\u4f7f\u7528 FDA \u4ea7\u54c1\u5206\u7c7b\u6570\u636e\u5e93\uff08Product Classification Database\uff09\u67e5\u8be2\u8c41\u514d\u6761\u4ef6<\/td><\/tr><tr><td><strong>2. \u5de5\u5382\u6ce8\u518c &amp; \u4ea7\u54c1\u5217\u540d<\/strong><\/td><td>\u5b8c\u6210 Establishment Registration \u4e0e Device Listing<\/td><\/tr><tr><td><strong>3. \u8d28\u91cf\u4f53\u7cfb\u9075\u5faa QSR<\/strong><\/td><td>\u786e\u4fdd\u7b26\u5408 21 CFR Part 820 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42<\/td><\/tr><tr><td><strong>4. \u6807\u7b7e\u4e0e UDI<\/strong><\/td><td>\u6807\u7b7e\u5185\u5bb9\u548c\u552f\u4e00\u5668\u68b0\u6807\u8bc6\u7b26\u7b26\u5408 FDA \u89c4\u8303<\/td><\/tr><tr><td><strong>5. \u5e74\u5ea6\u7ef4\u62a4<\/strong><\/td><td>\u6bcf\u5e74\u66f4\u65b0\u6ce8\u518c\u4fe1\u606f\u5e76\u5904\u7406\u4f53\u7cfb\u6216\u4ea7\u54c1\u53d8\u66f4<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">3. \u5173\u952e\u6ce8\u610f\u4e8b\u9879 &amp; \u5e38\u89c1\u8bef\u533a<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8bef\u533a\u4e00<\/strong>\uff1a\u8c41\u514d = \u65e0\u9700\u6ce8\u518c \u2192 \u9519\uff01\u4ecd\u9700\u6ce8\u518c\u4e0e\u5217\u540d\u3002<\/li>\n\n\n\n<li><strong>\u8bef\u533a\u4e8c<\/strong>\uff1a\u6240\u6709 Class I \u90fd\u8c41\u514d \u2192 \u90e8\u5206\u4f8b\u5916\u3002<\/li>\n\n\n\n<li><strong>\u8bef\u533a\u4e09<\/strong>\uff1a\u65e0\u9700 US Agent \u2192 \u5883\u5916\u4f01\u4e1a\u4ecd\u9700\u6307\u5b9a\u7f8e\u56fd\u4ee3\u7406\u4eba\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">4. \u6210\u529f\u6848\u4f8b<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6848\u4f8b A\uff08Class I \u624b\u672f\u5668\u68b0\uff09<\/strong><br>\u83b7\u5f97 510(k) \u8c41\u514d\u540e\uff0c\u901a\u8fc7\u4e13\u4e1a\u8f85\u5bfc\u5b8c\u6210\u6ce8\u518c\u3001UDI \u4e0e\u8d28\u91cf\u4f53\u7cfb\u5efa\u8bbe\uff0c\u6210\u529f\u8fdb\u5165\u533b\u9662\u91c7\u8d2d\u6e20\u9053\u3002<\/li>\n\n\n\n<li><strong>\u6848\u4f8b B\uff08Class II \u542c\u8bca\u5668\uff09<\/strong><br>\u521d\u671f\u8bef\u8ba4\u4e3a\u53ef\u8c41\u514d\uff0c\u8f85\u5bfc\u540e\u786e\u8ba4\u9700\u63d0\u4ea4 510(k)\uff0c\u5728\u4e13\u4e1a\u6307\u5bfc\u4e0b\u53ca\u65f6\u5b8c\u6210\u6ce8\u518c\uff0c\u907f\u514d\u4ea7\u54c1\u6ede\u7559\u5e02\u573a\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">5. \u884c\u52a8\u6307\u5357 &amp; \u63a8\u8350\u670d\u52a1<\/h3>\n\n\n\n<p>\u867d\u7136\u8c41\u514d 510(k) \u53ef\u964d\u4f4e\u90e8\u5206\u6ce8\u518c\u6210\u672c\uff0c\u4f46\u6ce8\u518c\u3001\u5217\u540d\u4e0e\u8d28\u91cf\u4f53\u7cfb\u4ecd\u662f\u5fc5\u987b\u9075\u5b88\u7684\u5173\u952e\u73af\u8282\u3002\u6b32\u4e86\u89e3\u5b8c\u6574 FDA \u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b\uff0c\u53ef\u8bbf\u95ee\u6211\u4eec\u7684\u8be6\u7ec6\u6307\u5357\uff1a<\/p>\n\n\n\n<p>\ud83d\udc49 <a href=\"https:\/\/www.fda-registered.com\/en\/medical-devices-fda-registration-analysis-entire-process\/\">\u533b\u7597\u5668\u68b0FDA\u6ce8\u518c\u5168\u6d41\u7a0b\u89e3\u6790<\/a><\/p>\n\n\n\n<p><strong>\u6211\u4eec\u63d0\u4f9b\u4e00\u7ad9\u5f0f\u670d\u52a1<\/strong>\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA 510(k) \u8c41\u514d\u5224\u65ad<\/li>\n\n\n\n<li>\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4e0e\u5217\u540d<\/li>\n\n\n\n<li>\u8d28\u91cf\u4f53\u7cfb\u8f85\u5bfc\uff08QSR \/ ISO 13485\uff09<\/li>\n\n\n\n<li>US Agent Service<\/li>\n\n\n\n<li>\u6587\u4ef6\u51c6\u5907\u4e0e\u5ba1\u6838\u652f\u6301<\/li>\n<\/ul>\n\n\n\n<p>\u7acb\u5373\u54a8\u8be2\uff0c\u8ba9\u60a8\u7684\u4ea7\u54c1\u5feb\u901f\u5408\u89c4\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u89e3\u6790 FDA 510(k) \u8c41\u514d\u6ce8\u518c\u5168\u6d41\u7a0b\uff1a\u6db5\u76d6\u4ea7\u54c1\u5206\u7c7b\u3001\u6ce8\u518c\u8981\u6c42\u3001\u8d28\u91cf\u4f53\u7cfb\u3001\u6807\u7b7e\u89c4\u8303\u53ca\u5e38\u89c1\u8bef\u533a\uff0c\u52a9\u529b\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5feb\u901f\u5408\u89c4\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u3002<\/p>","protected":false},"author":1,"featured_media":439,"comment_status":"open","ping_status":"open","sticky":false,"template":"template-single-sidebar","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7,11],"tags":[],"class_list":["post-438","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda-registration","category-medical-devices-fda-registration"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA 510(k) \u8c41\u514d\u6ce8\u518c\u5168\u6d41\u7a0b\u89e3\u6790 - \u8d39\u7f57\u838e | FDA \u6ce8\u518c\u54a8\u8be2\u670d\u52a1<\/title>\n<meta name=\"description\" content=\"\u672c\u6587\u5168\u9762\u89e3\u6790 FDA 510(k) \u8c41\u514d\u6ce8\u518c\u6d41\u7a0b\uff0c\u5e2e\u52a9\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5feb\u901f\u5224\u65ad\u4ea7\u54c1\u662f\u5426\u7b26\u5408\u8c41\u514d\u6761\u4ef6\u3002\u6587\u7ae0\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u8c41\u514d\u9002\u7528\u4ea7\u54c1\u8303\u56f4\u3001\u6ce8\u518c\u4e0e\u5217\u540d\u8981\u6c42\u3001\u8d28\u91cf\u4f53\u7cfb\u9075\u5faa\u3001\u6807\u7b7e\u4e0e UDI \u89c4\u8303\uff0c\u4ee5\u53ca\u5e74\u5ea6\u7ef4\u62a4\u4e0e\u5408\u89c4\u6ce8\u610f\u4e8b\u9879\u3002\u540c\u65f6\u901a\u8fc7\u6210\u529f\u6848\u4f8b\u5c55\u793a\u4f01\u4e1a\u5728\u8c41\u514d\u6ce8\u518c\u4e0b\u7684\u5b9e\u9645\u64cd\u4f5c\u7ecf\u3002\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.fda-registered.com\/en\/fda-510k-exemption-registration-services\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA 510(k) \u8c41\u514d\u6ce8\u518c\u5168\u6d41\u7a0b\u89e3\u6790 - \u8d39\u7f57\u838e | FDA \u6ce8\u518c\u54a8\u8be2\u670d\u52a1\" \/>\n<meta property=\"og:description\" content=\"\u672c\u6587\u5168\u9762\u89e3\u6790 FDA 510(k) \u8c41\u514d\u6ce8\u518c\u6d41\u7a0b\uff0c\u5e2e\u52a9\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5feb\u901f\u5224\u65ad\u4ea7\u54c1\u662f\u5426\u7b26\u5408\u8c41\u514d\u6761\u4ef6\u3002\u6587\u7ae0\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u8c41\u514d\u9002\u7528\u4ea7\u54c1\u8303\u56f4\u3001\u6ce8\u518c\u4e0e\u5217\u540d\u8981\u6c42\u3001\u8d28\u91cf\u4f53\u7cfb\u9075\u5faa\u3001\u6807\u7b7e\u4e0e UDI \u89c4\u8303\uff0c\u4ee5\u53ca\u5e74\u5ea6\u7ef4\u62a4\u4e0e\u5408\u89c4\u6ce8\u610f\u4e8b\u9879\u3002\u540c\u65f6\u901a\u8fc7\u6210\u529f\u6848\u4f8b\u5c55\u793a\u4f01\u4e1a\u5728\u8c41\u514d\u6ce8\u518c\u4e0b\u7684\u5b9e\u9645\u64cd\u4f5c\u7ecf\u3002\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.fda-registered.com\/en\/fda-510k-exemption-registration-services\/\" \/>\n<meta property=\"og:site_name\" content=\"\u8d39\u7f57\u838e | FDA \u6ce8\u518c\u54a8\u8be2\u670d\u52a1\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-27T08:13:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-08-27T08:13:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.fda-registered.com\/wp-content\/uploads\/2025\/08\/WechatIMG4738.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"fda-registered\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"fda-registered\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.fda-registered.com\\\/fda-510k-exemption-registration-services\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.fda-registered.com\\\/fda-510k-exemption-registration-services\\\/\"},\"author\":{\"name\":\"fda-registered\",\"@id\":\"https:\\\/\\\/www.fda-registered.com\\\/#\\\/schema\\\/person\\\/7b34bb57e3397f5d55406b47d5309111\"},\"headline\":\"FDA 510(k) 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