Omni Legend
K-Number: K221932 · 2022-09-02
ApplicantGE Healthcare
Decision Date2022-09-02
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Omni Legend is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2022-09-02 under approval number K221932. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Omni Legend?
Omni Legend is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by GE Healthcare. The 510(k) number is K221932.
When was Omni Legend approved by the FDA?
Omni Legend received FDA 510(k) clearance on 2022-09-02, under approval number K221932.
What company makes Omni Legend?
Omni Legend is manufactured by GE Healthcare.
What is the FDA product code for Omni Legend?
The FDA product code for Omni Legend is KPS.
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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.