FDA 510(k)

RAS 12 랙, RAS 12 장 랙; AMSCO 7052HP/7053HP 단실 세척/소독기의 RAS 주기

K-번호: K190081 · 2019-08-21

결정일2019-08-21

제품 코드NVE

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2019-08-21 under 510(k) number K190081. The device is classified under product code NVE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector?

RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is STERIS Corporation. The 510(k) number is K190081.

When did RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector receive FDA 510(k) clearance?

RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector received FDA 510(k) clearance on 2019-08-21, under 510(k) number K190081.

Who is the listed applicant for RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector?

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

What is the FDA product code for RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector?

The FDA product code for RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is NVE.

STERIS Corporation를 신청인으로 등재한 기타 기록

K261055AMSCO 700 스팀 스타일라이저 K260766캘러시티 5 HP 생물학적 지표 (LCB052)K251666SYSTEM 1E 액체 화학 소독제 처리 시스템, 모델 P6700; SYSTEM 1 엔도 액체 화학 소독제 처리 시스템, 모델 P6900 K252680셀러리티™ 20 HP 생물학적 지표 K251048라피시드 PA 고급 소독 테스트 스틱 모델 참조 번호 = ML02-0118 K243876STEAM 통합 지표 확인

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