FDA 510(k)

갈리켈 페이킹 튜브와 엔핏 커넥터

K-번호: K191784 · 2019-11-15

결정일2019-11-15

제품 코드PIF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Unknown

기기 요약

Gabriel Feeding Tube with Balloon, and EnFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Syncro Medical Innovations, Inc.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K191784. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

자주 묻는 질문

What is the Gabriel Feeding Tube with Balloon, and EnFit Connector?

Gabriel Feeding Tube with Balloon, and EnFit Connector is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Syncro Medical Innovations, Inc.. The 510(k) number is K191784.

When did Gabriel Feeding Tube with Balloon, and EnFit Connector receive FDA 510(k) clearance?

Gabriel Feeding Tube with Balloon, and EnFit Connector received FDA 510(k) clearance on 2019-11-15, under 510(k) number K191784.

Who is the listed applicant for Gabriel Feeding Tube with Balloon, and EnFit Connector?

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

What is the FDA product code for Gabriel Feeding Tube with Balloon, and EnFit Connector?

The FDA product code for Gabriel Feeding Tube with Balloon, and EnFit Connector is PIF.

Syncro Medical Innovations, Inc.를 신청인으로 등재한 기타 기록

K201741가브리엘 3웨이 엔핏 밸브 K160787갈리켈 피드 튜브, 마그네틱으로 지도되는 피드 튜브 w/발空气球, 갈리켈 피드 튜브, 스타일트와 함께 предустановленный

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