SIGNA Artist
K-Number: K202238 · 2020-09-04
Decision Date2020-09-04
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Artist is a medical device manufactured by Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2020-09-04 under approval number K202238. 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?
SIGNA Artist is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K202238.
When was SIGNA Artist approved by the FDA?
SIGNA Artist received FDA 510(k) clearance on 2020-09-04, under approval number K202238.
What company makes SIGNA Artist?
SIGNA Artist is manufactured by Ge Healthcare (Tianjin) Company Limited.
What is the FDA product code for SIGNA Artist?
The FDA product code for SIGNA Artist 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.