FDA 510(k)

SIGNA 챔피언

K-번호: K233728 · 2024-01-19

신청자Ge Healthcare (Tianjin) Company Limited

결정일2024-01-19

제품 코드LNH

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

결정대체적으로 동일

기기 요약

SIGNA Champion is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K233728. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SIGNA Champion?

SIGNA Champion is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K233728.

When did SIGNA Champion receive FDA 510(k) clearance?

SIGNA Champion received FDA 510(k) clearance on 2024-01-19, under 510(k) number K233728.

Who is the listed applicant for SIGNA Champion?

The FDA 510(k) record lists Ge Healthcare (Tianjin) Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNA Champion?

The FDA product code for SIGNA Champion is LNH.

Ge Healthcare (Tianjin) Company Limited를 신청인으로 등재한 기타 기록

K223439SIGNA Victor K213603SIGNA 아티스트 에보 K211980SIGNA 프라임 K202238SIGNA 아티스트 K192426시그나 보이저, 시그나 보이저 퀀텀

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