FDA 510(k)

Armis VeriCyn 疤痕清潔

K 號：K220759 · 2023-05-25

決定日期2023-05-25

產品代碼FQH

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Armis VeriCyn Wound Wash is the device name listed in this FDA 510(k) record. The listed applicant is Armis Biopharma, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K220759. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Armis VeriCyn Wound Wash?

Armis VeriCyn Wound Wash is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Armis Biopharma, Inc.. The 510(k) number is K220759.

When did Armis VeriCyn Wound Wash receive FDA 510(k) clearance?

Armis VeriCyn Wound Wash received FDA 510(k) clearance on 2023-05-25, under 510(k) number K220759.

Who is the listed applicant for Armis VeriCyn Wound Wash?

The FDA 510(k) record lists Armis Biopharma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Armis VeriCyn Wound Wash?

The FDA product code for Armis VeriCyn Wound Wash is FQH.

其他以 Armis Biopharma, Inc. 為申請人之記錄

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官方來源

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