SIGNA Hero
K-Number: K213668 · 2022-01-20
Decision Date2022-01-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Hero is a medical device manufactured by Ge Healthcare (Ge Medical Systems, LLC). It received FDA 510(k) clearance on 2022-01-20 under approval number K213668. 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 Hero?
SIGNA Hero is a medical device that received FDA 510(k) clearance on 2022-01-20. It is manufactured by Ge Healthcare (Ge Medical Systems, LLC). The 510(k) number is K213668.
When was SIGNA Hero approved by the FDA?
SIGNA Hero received FDA 510(k) clearance on 2022-01-20, under approval number K213668.
What company makes SIGNA Hero?
SIGNA Hero is manufactured by Ge Healthcare (Ge Medical Systems, LLC).
What is the FDA product code for SIGNA Hero?
The FDA product code for SIGNA Hero is LNH.
Other Devices by Ge Healthcare (Ge Medical Systems, LLC)
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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.