FDA 510(k)

醫用保護口罩

K 號：K202358 · 2021-01-29

申請人Hunan Heng Chang Pharmaceutical Co., Ltd.

決定日期2021-01-29

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

Protective Face Mask for Medical Use is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Heng Chang Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K202358. 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 Protective Face Mask for Medical Use?

Protective Face Mask for Medical Use is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Hunan Heng Chang Pharmaceutical Co., Ltd.. The 510(k) number is K202358.

When did Protective Face Mask for Medical Use receive FDA 510(k) clearance?

Protective Face Mask for Medical Use received FDA 510(k) clearance on 2021-01-29, under 510(k) number K202358.

Who is the listed applicant for Protective Face Mask for Medical Use?

The FDA 510(k) record lists Hunan Heng Chang Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protective Face Mask for Medical Use?

The FDA product code for Protective Face Mask for Medical Use is FXX.

其他以 Hunan Heng Chang Pharmaceutical 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。

K202354外科口罩-型號 CW01

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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