FDA 510(k)

Andorate Biopsy Valve, Andorate Biopsy Irrigator

K号: K200481 · 2020-06-18

决定日期2020-06-18

产品代码ODC

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决定实质等同

器械摘要

Andorate Biopsy Valve, Andorate Biopsy Irrigator 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 2020-06-18 under 510(k) number K200481. 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 Biopsy Valve, Andorate Biopsy Irrigator?

Andorate Biopsy Valve, Andorate Biopsy Irrigator is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Ga Health Company Limited. The 510(k) number is K200481.

When did Andorate Biopsy Valve, Andorate Biopsy Irrigator receive FDA 510(k) clearance?

Andorate Biopsy Valve, Andorate Biopsy Irrigator received FDA 510(k) clearance on 2020-06-18, under 510(k) number K200481.

Who is the listed applicant for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

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 Biopsy Valve, Andorate Biopsy Irrigator?

The FDA product code for Andorate Biopsy Valve, Andorate Biopsy Irrigator 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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