FDA 510(k)

安道瑞吸阀，安道瑞气/水阀

K号: K213095 · 2022-01-12

决定日期2022-01-12

产品代码ODC

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

andorate Suction Valve, andorate Air/Water 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 2022-01-12 under 510(k) number K213095. 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 Suction Valve, andorate Air/Water Valve?

andorate Suction Valve, andorate Air/Water Valve is a medical device that received FDA 510(k) clearance on 2022-01-12. The listed applicant is Ga Health Company Limited. The 510(k) number is K213095.

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

andorate Suction Valve, andorate Air/Water Valve received FDA 510(k) clearance on 2022-01-12, under 510(k) number K213095.

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

The FDA product code for andorate Suction Valve, andorate Air/Water 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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