FDA 510(k)

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

K-번호: K211827 · 2021-09-23

신청자Zhejiang Lanhine Medical Products, Ltd.

결정일2021-09-23

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211827. 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 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. The 510(k) number is K211827.

When did Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) receive FDA 510(k) clearance?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211827.

Who is the listed applicant for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

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

What is the FDA product code for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

The FDA product code for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is FXX.

Zhejiang Lanhine Medical Products, Ltd.를 신청인으로 등재한 기타 기록

K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

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