FDA 510(k)

Asept 外科臉部口罩

K 號：K201137 · 2020-08-19

決定日期2020-08-19

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

Asept Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K201137. 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 Asept Surgical Face Mask?

Asept Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K201137.

When did Asept Surgical Face Mask receive FDA 510(k) clearance?

Asept Surgical Face Mask received FDA 510(k) clearance on 2020-08-19, under 510(k) number K201137.

Who is the listed applicant for Asept Surgical Face Mask?

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

What is the FDA product code for Asept Surgical Face Mask?

The FDA product code for Asept Surgical Face Mask is FXX.

其他以 Pfm Medical, Inc. 為申請人之記錄

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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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