FDA 510(k)

程序口罩，外科口罩

K 號：K202899 · 2021-05-20

決定日期2021-05-20

產品代碼FXX

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

Procedure Mask, Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Kenpax International Limited. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K202899. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Procedure Mask, Surgical Mask?

Procedure Mask, Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Kenpax International Limited. The 510(k) number is K202899.

When did Procedure Mask, Surgical Mask receive FDA 510(k) clearance?

Procedure Mask, Surgical Mask received FDA 510(k) clearance on 2021-05-20, under 510(k) number K202899.

Who is the listed applicant for Procedure Mask, Surgical Mask?

The FDA 510(k) record lists Kenpax International Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Procedure Mask, Surgical Mask?

The FDA product code for Procedure Mask, Surgical Mask is FXX.

其他以 Kenpax International Limited 為申請人之記錄

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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相關器械（代碼：FXX）

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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