FDA 510(k)

3M 高性能外科口罩，3M 高性能外科口罩配面罩

K 號：K180874 · 2018-07-31

決定日期2018-07-31

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 Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2018-07-31 under 510(k) number K180874. 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 Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is a medical device that received FDA 510(k) clearance on 2018-07-31. The listed applicant is 3M Healthcare. The 510(k) number is K180874.

When did 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield receive FDA 510(k) clearance?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield received FDA 510(k) clearance on 2018-07-31, under 510(k) number K180874.

Who is the listed applicant for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

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 Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is FXX.

其他以 3M Healthcare 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。

K251967HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶；HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶，並附帶 WrapAround Visor。O&M Halyard, Inc.K252534外科口罩（耳掛式）Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性外科口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性醫療口罩Makrite Industries, Inc.K243342KP防護口罩Kp Trading Co., Ltd.

官方來源

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