SIGNA Artist Evo
K-Number: K213603 · 2022-02-11
Decision Date2022-02-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Artist Evo is a medical device manufactured by Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2022-02-11 under approval number K213603. 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 Artist Evo?
SIGNA Artist Evo is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K213603.
When was SIGNA Artist Evo approved by the FDA?
SIGNA Artist Evo received FDA 510(k) clearance on 2022-02-11, under approval number K213603.
What company makes SIGNA Artist Evo?
SIGNA Artist Evo is manufactured by Ge Healthcare (Tianjin) Company Limited.
What is the FDA product code for SIGNA Artist Evo?
The FDA product code for SIGNA Artist Evo is LNH.
Other Devices by Ge Healthcare (Tianjin) Company Limited
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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.