FDA 510(k)

一次性手术服 UM-148

K号: K221717 · 2022-09-20

决定日期2022-09-20

产品代码FYA

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决定实质等同

器械摘要

Disposable Surgical Gown UM-148 is the device name listed in this FDA 510(k) record. The listed applicant is Unimax Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K221717. 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 Disposable Surgical Gown UM-148?

Disposable Surgical Gown UM-148 is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Unimax Medical Products Co., Ltd.. The 510(k) number is K221717.

When did Disposable Surgical Gown UM-148 receive FDA 510(k) clearance?

Disposable Surgical Gown UM-148 received FDA 510(k) clearance on 2022-09-20, under 510(k) number K221717.

Who is the listed applicant for Disposable Surgical Gown UM-148?

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

What is the FDA product code for Disposable Surgical Gown UM-148?

The FDA product code for Disposable Surgical Gown UM-148 is FYA.

列明Unimax Medical Products 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。

K220749外科手术口罩，型号-17.5X9.5CM 耳挂式

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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