SIGNA Champion
K-Number: K233728 · 2024-01-19
Decision Date2024-01-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Champion is a medical device manufactured by Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2024-01-19 under approval number K233728. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SIGNA Champion?
SIGNA Champion is a medical device that received FDA 510(k) clearance on 2024-01-19. It is manufactured by Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K233728.
When was SIGNA Champion approved by the FDA?
SIGNA Champion received FDA 510(k) clearance on 2024-01-19, under approval number K233728.
What company makes SIGNA Champion?
SIGNA Champion is manufactured by Ge Healthcare (Tianjin) Company Limited.
What is the FDA product code for SIGNA Champion?
The FDA product code for SIGNA Champion is LNH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.