FDA 510(k)

标准外科服（AAMI Level 2）；加固外科服（AAMI Level 2）

K号: K222480 · 2022-11-14

决定日期2022-11-14

产品代码FYA

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决定实质等同

器械摘要

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) 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 2022-11-14 under 510(k) number K222480. 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 Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K222480.

When did Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) receive FDA 510(k) clearance?

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) received FDA 510(k) clearance on 2022-11-14, under 510(k) number K222480.

Who is the listed applicant for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

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 Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

The FDA product code for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) 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。

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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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