FDA 510(k)

一次性醫療口罩

K 號：K214085 · 2022-04-06

申請人Hubei Wanli Protective Products Co., Ltd.

決定日期2022-04-06

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

Disposable Medical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Wanli Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-04-06 under 510(k) number K214085. 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 Disposable Medical Mask?

Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Hubei Wanli Protective Products Co., Ltd.. The 510(k) number is K214085.

When did Disposable Medical Mask receive FDA 510(k) clearance?

Disposable Medical Mask received FDA 510(k) clearance on 2022-04-06, under 510(k) number K214085.

Who is the listed applicant for Disposable Medical Mask?

The FDA 510(k) record lists Hubei Wanli Protective Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Mask?

The FDA product code for Disposable Medical Mask is FXX.

其他以 Hubei Wanli Protective Products 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。

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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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