FDA 510(k)

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask

K 號：K191355 · 2019-09-11

決定日期2019-09-11

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

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2019-09-11 under 510(k) number K191355. 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 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask?

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is 3M Healthcare. The 510(k) number is K191355.

When did 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask receive FDA 510(k) clearance?

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask received FDA 510(k) clearance on 2019-09-11, under 510(k) number K191355.

Who is the listed applicant for 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask?

The FDA product code for 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask is FXX.

其他以 3M Healthcare 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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