FDA 510(k)

醫療外科口罩（型號：ZKM-U01（非无菌型 17.5公分×9.5公分））

K 號：K212460 · 2021-11-05

申請人Guangzhou Zhengkang Medical Equipment Co.,Ltd

決定日期2021-11-05

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

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Zhengkang Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K212460. 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 Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Guangzhou Zhengkang Medical Equipment Co.,Ltd. The 510(k) number is K212460.

When did Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) receive FDA 510(k) clearance?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) received FDA 510(k) clearance on 2021-11-05, under 510(k) number K212460.

Who is the listed applicant for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

The FDA 510(k) record lists Guangzhou Zhengkang Medical Equipment Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

The FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is FXX.

其他以 Guangzhou Zhengkang Medical Equipment Co.,Ltd 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。

K222204醫療外科口罩

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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