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FDA 510(k)

Hydrozid精準

K 號：K221897 · 2023-05-30

申請人Bibawo Medical A/S
決定日期2023-05-30
產品代碼GEH
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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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官方來源

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