FDA 510(k)

3M Attest 증발 수소 Peroxide Tri-Metric 화학 지표 1348/1348E

K-번호: K193110 · 2020-03-13

결정일2020-03-13

제품 코드QKM

자문 위원회HO

결정Substantially Equivalent

기기 요약

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K193110. The device is classified under product code QKM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is 3M Healthcare. The 510(k) number is K193110.

When did 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E receive FDA 510(k) clearance?

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E received FDA 510(k) clearance on 2020-03-13, under 510(k) number K193110.

Who is the listed applicant for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

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 Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

The FDA product code for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is QKM.

3M Healthcare를 신청인으로 등재한 기타 기록

K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask K1808743M High Performance 수술 마스크, 3M High Performance 수술 마스크 with Face Shield 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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