FDA 510(k)

enspire 300 Series Automated Endoscope Reprocessor

K-번호: K232918 · 2023-10-03

결정일2023-10-03

제품 코드NZA

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

enspire 300 Series Automated Endoscope Reprocessor is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232918. The device is classified under product code NZA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the enspire 300 Series Automated Endoscope Reprocessor?

enspire 300 Series Automated Endoscope Reprocessor is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is STERIS Corporation. The 510(k) number is K232918.

When did enspire 300 Series Automated Endoscope Reprocessor receive FDA 510(k) clearance?

enspire 300 Series Automated Endoscope Reprocessor received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232918.

Who is the listed applicant for enspire 300 Series Automated Endoscope Reprocessor?

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 enspire 300 Series Automated Endoscope Reprocessor?

The FDA product code for enspire 300 Series Automated Endoscope Reprocessor is NZA.

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 K243876VERIFY STEAM Integrating Indicator

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