FDA 510(k)

標準程序口罩，標準外科口罩

K 號：K202605 · 2021-02-10

申請人Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

決定日期2021-02-10

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

Standard Procedure Mask, Standard Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-02-10 under 510(k) number K202605. 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 Standard Procedure Mask, Standard Surgical Mask?

Standard Procedure Mask, Standard Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. The 510(k) number is K202605.

When did Standard Procedure Mask, Standard Surgical Mask receive FDA 510(k) clearance?

Standard Procedure Mask, Standard Surgical Mask received FDA 510(k) clearance on 2021-02-10, under 510(k) number K202605.

Who is the listed applicant for Standard Procedure Mask, Standard Surgical Mask?

The FDA 510(k) record lists Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Standard Procedure Mask, Standard Surgical Mask?

The FDA product code for Standard Procedure Mask, Standard Surgical Mask is FXX.

其他以 Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. 為申請人之記錄

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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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