FDA 510(k)

Plus Medical 化疗病袍

K号: K211036 · 2022-05-04

决定日期2022-05-04

产品代码FYA

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决定实质等同

器械摘要

Plus Medical Chemotherapy Gown is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K211036. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Plus Medical Chemotherapy Gown?

Plus Medical Chemotherapy Gown is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K211036.

When did Plus Medical Chemotherapy Gown receive FDA 510(k) clearance?

Plus Medical Chemotherapy Gown received FDA 510(k) clearance on 2022-05-04, under 510(k) number K211036.

Who is the listed applicant for Plus Medical Chemotherapy Gown?

The FDA 510(k) record lists Foshan Nanhai Plus Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Plus Medical Chemotherapy Gown?

The FDA product code for Plus Medical Chemotherapy Gown is FYA.

列明Foshan Nanhai Plus Medical Co, Ltd.为申报人的其他记录

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。

K222480标准外科服（AAMI Level 2）；加固外科服（AAMI Level 2）K213177Plus Medical 防护服 K212698Plus Medical 三级隔离服 K212610Surgical Face Mask K210143标准外科服（AAMI Level 3），加固外科服（AAMI Level 3）

相关器械（代码：FYA）

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。

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官方来源

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