FDA 510(k)

外科口罩

K 號：K202191 · 2021-03-29

申請人Wuhan Zonsen Medical Products Co., Ltd.

決定日期2021-03-29

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

Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-29 under 510(k) number K202191. 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 Surgical Mask?

Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-03-29. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K202191.

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

Surgical Mask received FDA 510(k) clearance on 2021-03-29, under 510(k) number K202191.

Who is the listed applicant for Surgical Mask?

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

What is the FDA product code for Surgical Mask?

The FDA product code for Surgical Mask is FXX.

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