FDA 510(k)

3PLY 디스포제블 의료 마스크

K-번호: K223045 · 2022-12-07

결정일2022-12-07

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

3-Ply Disposable Medical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wealth Lead Industrial Limited. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K223045. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 3-Ply Disposable Medical Mask?

3-Ply Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Wealth Lead Industrial Limited. The 510(k) number is K223045.

When did 3-Ply Disposable Medical Mask receive FDA 510(k) clearance?

3-Ply Disposable Medical Mask received FDA 510(k) clearance on 2022-12-07, under 510(k) number K223045.

Who is the listed applicant for 3-Ply Disposable Medical Mask?

The FDA 510(k) record lists Wealth Lead Industrial Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3-Ply Disposable Medical Mask?

The FDA product code for 3-Ply Disposable Medical Mask is FXX.

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3PLY 디스포제블 의료 마스크

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FXX)

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