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FDA 510(k)

D-Care外科口罩3層，D-Care醫用口罩3層

K 號：K213970 · 2022-01-23

申請人Danameco Medical Joint Stock Corporation
決定日期2022-01-23
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

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is the device name listed in this FDA 510(k) record. The listed applicant is Danameco Medical Joint Stock Corporation. It received FDA 510(k) clearance on 2022-01-23 under 510(k) number K213970. 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 D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is a medical device that received FDA 510(k) clearance on 2022-01-23. The listed applicant is Danameco Medical Joint Stock Corporation. The 510(k) number is K213970.

When did D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply receive FDA 510(k) clearance?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply received FDA 510(k) clearance on 2022-01-23, under 510(k) number K213970.

Who is the listed applicant for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

The FDA 510(k) record lists Danameco Medical Joint Stock Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

The FDA product code for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is FXX.

相關臨床試驗

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。

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官方來源

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