FDA 510(k)

雅度手术服

K号: K220092 · 2022-10-07

决定日期2022-10-07

产品代码FYA

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决定实质等同

器械摘要

YADU Surgical Gowns is the device name listed in this FDA 510(k) record. The listed applicant is Henan Yadu Industrial Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K220092. 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 YADU Surgical Gowns?

YADU Surgical Gowns is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Henan Yadu Industrial Co., Ltd.. The 510(k) number is K220092.

When did YADU Surgical Gowns receive FDA 510(k) clearance?

YADU Surgical Gowns received FDA 510(k) clearance on 2022-10-07, under 510(k) number K220092.

Who is the listed applicant for YADU Surgical Gowns?

The FDA 510(k) record lists Henan Yadu Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YADU Surgical Gowns?

The FDA product code for YADU Surgical Gowns is FYA.

列明Henan Yadu Industrial 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。

K212330雅度医疗一级医用口罩

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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