FDA 510(k)

에디 캐시터 ENFit

K-번호: K153688 · 2017-03-02

결정일2017-03-02

제품 코드PIF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Edi Catheter ENFit is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Critical Care AB. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K153688. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Edi Catheter ENFit?

Edi Catheter ENFit is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Maquet Critical Care AB. The 510(k) number is K153688.

When did Edi Catheter ENFit receive FDA 510(k) clearance?

Edi Catheter ENFit received FDA 510(k) clearance on 2017-03-02, under 510(k) number K153688.

Who is the listed applicant for Edi Catheter ENFit?

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

What is the FDA product code for Edi Catheter ENFit?

The FDA product code for Edi Catheter ENFit is PIF.

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