FDA 510(k)

완전 통제 시스템 Gen2

K-번호: K191083 · 2019-05-24

결정일2019-05-24

제품 코드GXY

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

결정대체적으로 동일

기기 요약

COMPLETE CONTROL System Gen2 is the device name listed in this FDA 510(k) record. The listed applicant is Coapt, LLC. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K191083. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the COMPLETE CONTROL System Gen2?

COMPLETE CONTROL System Gen2 is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Coapt, LLC. The 510(k) number is K191083.

When did COMPLETE CONTROL System Gen2 receive FDA 510(k) clearance?

COMPLETE CONTROL System Gen2 received FDA 510(k) clearance on 2019-05-24, under 510(k) number K191083.

Who is the listed applicant for COMPLETE CONTROL System Gen2?

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

What is the FDA product code for COMPLETE CONTROL System Gen2?

The FDA product code for COMPLETE CONTROL System Gen2 is GXY.

Coapt, LLC를 신청인으로 등재한 기타 기록

K190416도메 전극 K162891완전 제어 시스템

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