FDA 510(k)

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve

K号: K200495 · 2020-06-24

决定日期2020-06-24

产品代码ODC

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决定实质等同

器械摘要

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2020-06-24 under 510(k) number K200495. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve?

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve is a medical device that received FDA 510(k) clearance on 2020-06-24. The listed applicant is Ga Health Company Limited. The 510(k) number is K200495.

When did Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve receive FDA 510(k) clearance?

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve received FDA 510(k) clearance on 2020-06-24, under 510(k) number K200495.

Who is the listed applicant for Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve?

The FDA product code for Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve is ODC.

列明Ga Health Company Limited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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官方来源

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