FDA 510(k)

單次使用醫用口罩

K 號：K203591 · 2021-07-02

決定日期2021-07-02

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

Single-use Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Conod Medical Co., Limited. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K203591. 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 Single-use Medical Face Mask?

Single-use Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Conod Medical Co., Limited. The 510(k) number is K203591.

When did Single-use Medical Face Mask receive FDA 510(k) clearance?

Single-use Medical Face Mask received FDA 510(k) clearance on 2021-07-02, under 510(k) number K203591.

Who is the listed applicant for Single-use Medical Face Mask?

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

What is the FDA product code for Single-use Medical Face Mask?

The FDA product code for Single-use Medical Face Mask is FXX.

其他以 Conod Medical Co., Limited 為申請人之記錄

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K181276CONOD腸內營養輸注套件

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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