FDA 510(k)

스코프 버디 플러스 엔도스코프 씻기 도구

K-번호: K162128 · 2016-12-21

결정일2016-12-21

제품 코드FEB

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Scope Buddy Plus Endoscope Flushing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162128. 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 Scope Buddy Plus Endoscope Flushing Aid?

Scope Buddy Plus Endoscope Flushing Aid is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Medivators, Inc.. The 510(k) number is K162128.

When did Scope Buddy Plus Endoscope Flushing Aid receive FDA 510(k) clearance?

Scope Buddy Plus Endoscope Flushing Aid received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162128.

Who is the listed applicant for Scope Buddy Plus Endoscope Flushing Aid?

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

What is the FDA product code for Scope Buddy Plus Endoscope Flushing Aid?

The FDA product code for Scope Buddy Plus Endoscope Flushing Aid is FEB.

Medivators, Inc.를 신청인으로 등재한 기타 기록

K223040엔도 스마트케이프 K213833BUDDY PLUS 내시경 씻기 보조 장치 K172677Advantage Plus Pass-Thru K160846AmplifEYE K152394라피시드 PA 고급 소독제 테스트 스틱

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