FDA 510(k)

모노젝 엔피트 커넥터 장착 엔터알 페이킹 주사기

K-번호: K160419 · 2016-05-12

결정일2016-05-12

제품 코드PNR

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Monoject Enteral Feeding Syringe with ENFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K160419. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Monoject Enteral Feeding Syringe with ENFit Connector?

Monoject Enteral Feeding Syringe with ENFit Connector is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Covidien. The 510(k) number is K160419.

When did Monoject Enteral Feeding Syringe with ENFit Connector receive FDA 510(k) clearance?

Monoject Enteral Feeding Syringe with ENFit Connector received FDA 510(k) clearance on 2016-05-12, under 510(k) number K160419.

Who is the listed applicant for Monoject Enteral Feeding Syringe with ENFit Connector?

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

What is the FDA product code for Monoject Enteral Feeding Syringe with ENFit Connector?

The FDA product code for Monoject Enteral Feeding Syringe with ENFit Connector is PNR.

Covidien를 신청인으로 등재한 기타 기록

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