FDA 510(k)

一次性隔離袍（S，M，L，XL，XXL，XXXL）

K 號：K223304 · 2023-02-08

申請人Xiamen Probtain Medical Technology Co., Ltd.

決定日期2023-02-08

產品代碼FYC

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 Isolation Gowns (S,M,L,XL,XXL,XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Probtain Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K223304. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Xiamen Probtain Medical Technology Co., Ltd.. The 510(k) number is K223304.

When did Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) receive FDA 510(k) clearance?

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-02-08, under 510(k) number K223304.

Who is the listed applicant for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

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

What is the FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?

The FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is FYC.

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FYC）

官方來源