FDA 510(k)

3M High Performance 수술 마스크, 3M High Performance 수술 마스크 with Face Shield

K-번호: K180874 · 2018-07-31

결정일2018-07-31

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2018-07-31 under 510(k) number K180874. 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 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is a medical device that received FDA 510(k) clearance on 2018-07-31. The listed applicant is 3M Healthcare. The 510(k) number is K180874.

When did 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield receive FDA 510(k) clearance?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield received FDA 510(k) clearance on 2018-07-31, under 510(k) number K180874.

Who is the listed applicant for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is FXX.

3M Healthcare를 신청인으로 등재한 기타 기록

K1931103M Attest 증발 수소 Peroxide Tri-Metric 화학 지표 1348/1348E K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask K1804043M Clarity Ultra 자동 조이링 브래킷 및 접착제 코팅 애플리케이션 시스템 K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S K153571Cavilon Advanced High Endurance Skin Protectant

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