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FDA 510(k)

EMS腰带(型号MC0485)

K号: K183103 · 2019-09-18

决定日期2019-09-18
产品代码NGX
咨询委员会PM 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

EMS Belt (Model MC0485) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Yingfeng Metal & Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K183103. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EMS Belt (Model MC0485)?

EMS Belt (Model MC0485) is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Dongguan Yingfeng Metal & Plastic Products Co., Ltd.. The 510(k) number is K183103.

When did EMS Belt (Model MC0485) receive FDA 510(k) clearance?

EMS Belt (Model MC0485) received FDA 510(k) clearance on 2019-09-18, under 510(k) number K183103.

Who is the listed applicant for EMS Belt (Model MC0485)?

The FDA 510(k) record lists Dongguan Yingfeng Metal & Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS Belt (Model MC0485)?

The FDA product code for EMS Belt (Model MC0485) is NGX.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

相关器械(代码:NGX)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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