FDA 510(k)

VersaWrap

K 號：K213163 · 2021-10-29

決定日期2021-10-29

產品代碼FTM

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

VersaWrap is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K213163. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VersaWrap?

VersaWrap is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Alafair Biosciences, Inc.. The 510(k) number is K213163.

When did VersaWrap receive FDA 510(k) clearance?

VersaWrap received FDA 510(k) clearance on 2021-10-29, under 510(k) number K213163.

Who is the listed applicant for VersaWrap?

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

What is the FDA product code for VersaWrap?

The FDA product code for VersaWrap is FTM.

其他以 Alafair Biosciences, Inc. 為申請人之記錄

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相關器械（代碼：FTM）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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