FDA 510(k)

一次性尿液收集管

K号: K220739 · 2022-11-17

申请人Zhejiang Gongdong Medical Technology Co., Ltd.

决定日期2022-11-17

产品代码JSM

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决定实质等同

器械摘要

Disposable Urine Collection Tube is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Gongdong Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K220739. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Urine Collection Tube?

Disposable Urine Collection Tube is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Zhejiang Gongdong Medical Technology Co., Ltd.. The 510(k) number is K220739.

When did Disposable Urine Collection Tube receive FDA 510(k) clearance?

Disposable Urine Collection Tube received FDA 510(k) clearance on 2022-11-17, under 510(k) number K220739.

Who is the listed applicant for Disposable Urine Collection Tube?

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

What is the FDA product code for Disposable Urine Collection Tube?

The FDA product code for Disposable Urine Collection Tube is JSM.

列明Zhejiang Gongdong Medical Technology 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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