FDA 510(k)

JiveX (모델 번호 / 출시: 5.4)

K-번호: K231041 · 2023-07-14

결정일2023-07-14

제품 코드LLZ

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

JiveX (Model Number / Release: 5.4) is the device name listed in this FDA 510(k) record. The listed applicant is Visus Health IT GmbH. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K231041. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the JiveX (Model Number / Release: 5.4)?

JiveX (Model Number / Release: 5.4) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Visus Health IT GmbH. The 510(k) number is K231041.

When did JiveX (Model Number / Release: 5.4) receive FDA 510(k) clearance?

JiveX (Model Number / Release: 5.4) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K231041.

Who is the listed applicant for JiveX (Model Number / Release: 5.4)?

The FDA 510(k) record lists Visus Health IT GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JiveX (Model Number / Release: 5.4)?

The FDA product code for JiveX (Model Number / Release: 5.4) is LLZ.

Visus Health IT GmbH를 신청인으로 등재한 기타 기록

K212321JiveX (모델 번호 / 출시: 5.3)K200703지브엑스 K181964지브엑스

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