FDA 510(k)

Fidmi 저부피 엔터럴 영양 공급 장치

K-번호: K191844 · 2019-09-30

결정일2019-09-30

제품 코드KGC

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Fidmi Low Profile Enteral Feeding Device is the device name listed in this FDA 510(k) record. The listed applicant is Fidmi Medical, Ltd.. It received FDA 510(k) clearance on 2019-09-30 under 510(k) number K191844. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Fidmi Low Profile Enteral Feeding Device?

Fidmi Low Profile Enteral Feeding Device is a medical device that received FDA 510(k) clearance on 2019-09-30. The listed applicant is Fidmi Medical, Ltd.. The 510(k) number is K191844.

When did Fidmi Low Profile Enteral Feeding Device receive FDA 510(k) clearance?

Fidmi Low Profile Enteral Feeding Device received FDA 510(k) clearance on 2019-09-30, under 510(k) number K191844.

Who is the listed applicant for Fidmi Low Profile Enteral Feeding Device?

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

What is the FDA product code for Fidmi Low Profile Enteral Feeding Device?

The FDA product code for Fidmi Low Profile Enteral Feeding Device is KGC.

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Fidmi 저부피 엔터럴 영양 공급 장치

기기 요약

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관련 임상시험

관련 기기 (코드: KGC)

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