FDA 510(k)

ENvizion 메디칼 ENvue ENvizion 메디칼 엔터알 페이킹 튜브

K-번호: K203133 · 2021-03-24

결정일2021-03-24

제품 코드KNT

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube is the device name listed in this FDA 510(k) record. The listed applicant is Envizion Medical , Ltd.. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K203133. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube?

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Envizion Medical , Ltd.. The 510(k) number is K203133.

When did ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube receive FDA 510(k) clearance?

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance on 2021-03-24, under 510(k) number K203133.

Who is the listed applicant for ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube?

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

What is the FDA product code for ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube?

The FDA product code for ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube is KNT.

Envizion Medical , Ltd.를 신청인으로 등재한 기타 기록

K191387ENvizion 메디칼 ENVue 시스템, ENvizion 메디칼 엔터알 페이킹 튜브 K182915ENvizion 메디칼 ENvue; ENvizion 메디칼 엔터알 페이킹 튜브

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