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FDA 510(k)

Hydrozid精确型

K号: K221897 · 2023-05-30

申请人Bibawo Medical A/S
决定日期2023-05-30
产品代码GEH
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Hydrozid Precise is the device name listed in this FDA 510(k) record. The listed applicant is Bibawo Medical A/S. It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K221897. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hydrozid Precise?

Hydrozid Precise is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Bibawo Medical A/S. The 510(k) number is K221897.

When did Hydrozid Precise receive FDA 510(k) clearance?

Hydrozid Precise received FDA 510(k) clearance on 2023-05-30, under 510(k) number K221897.

Who is the listed applicant for Hydrozid Precise?

The FDA 510(k) record lists Bibawo Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hydrozid Precise?

The FDA product code for Hydrozid Precise is GEH.

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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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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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