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FDA 510(k)

CAREWE外科口罩型號N001-AW、N002-AW及N003-AW

K 號：K203078 · 2022-08-19

申請人Huizhou Tianchang Industrial Co., Ltd.
決定日期2022-08-19
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

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Tianchang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K203078. 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 CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Huizhou Tianchang Industrial Co., Ltd.. The 510(k) number is K203078.

When did CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW receive FDA 510(k) clearance?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW received FDA 510(k) clearance on 2022-08-19, under 510(k) number K203078.

Who is the listed applicant for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

The FDA 510(k) record lists Huizhou Tianchang Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

The FDA product code for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is FXX.

相關臨床試驗

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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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