FDA 510(k)

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

K-번호: K223411 · 2023-01-04

신청자Xiamen Probtain Medical Techology Co., Ltd.

결정일2023-01-04

제품 코드FYC

자문 위원회SU

결정Substantially Equivalent

기기 요약

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 Techology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K223411. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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 2023-01-04. The listed applicant is Xiamen Probtain Medical Techology Co., Ltd.. The 510(k) number is K223411.

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 2023-01-04, under 510(k) number K223411.

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

The FDA 510(k) record lists Xiamen Probtain Medical Techology 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.

Xiamen Probtain Medical Techology Co., Ltd.를 신청인으로 등재한 기타 기록

K223401Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)K202954Disposable Surgical Mask K201893Disposable Surgical Mask

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