FDA 510(k)

AEROFLEX™ 자동 내시경 재처리기 with AUTOSURE™ MRC 모니터

K-번호: K181472 · 2019-04-23

신청자Advanced Sterilization Products (Asp)

결정일2019-04-23

제품 코드FEB

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2019-04-23 under 510(k) number K181472. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is a medical device that received FDA 510(k) clearance on 2019-04-23. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K181472.

When did AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor receive FDA 510(k) clearance?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor received FDA 510(k) clearance on 2019-04-23, under 510(k) number K181472.

Who is the listed applicant for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

The FDA 510(k) record lists Advanced Sterilization Products (Asp) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

The FDA product code for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is FEB.

Advanced Sterilization Products (Asp)를 신청인으로 등재한 기타 기록

K192025STERRAD VELOCITY 생물학적 지표/과정 도전 장치 및 리더 K182404STERRAD VELOCITY 생물학적 지표 K170039STERRAD VELOCITY 생물지표 및 리더 K152189에보텍 ECR

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