FDA 510(k)

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K-번호: K171384 · 2018-02-01

결정일2018-02-01

제품 코드GWQ

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정Substantially Equivalent

기기 요약

Micromed BRAIN QUICK system is the device name listed in this FDA 510(k) record. The listed applicant is Micromed S.P.A.. It received FDA 510(k) clearance on 2018-02-01 under 510(k) number K171384. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Micromed BRAIN QUICK system?

Micromed BRAIN QUICK system is a medical device that received FDA 510(k) clearance on 2018-02-01. The listed applicant is Micromed S.P.A.. The 510(k) number is K171384.

When did Micromed BRAIN QUICK system receive FDA 510(k) clearance?

Micromed BRAIN QUICK system received FDA 510(k) clearance on 2018-02-01, under 510(k) number K171384.

Who is the listed applicant for Micromed BRAIN QUICK system?

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

What is the FDA product code for Micromed BRAIN QUICK system?

The FDA product code for Micromed BRAIN QUICK system is GWQ.

Micromed S.P.A.를 신청인으로 등재한 기타 기록

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