VIVACE
K-Number: K232047 · 2024-03-28
ApplicantUnimom.Co
Decision Date2024-03-28
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
VIVACE is a medical device manufactured by Unimom.Co. It received FDA 510(k) clearance on 2024-03-28 under approval number K232047. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VIVACE?
VIVACE is a medical device that received FDA 510(k) clearance on 2024-03-28. It is manufactured by Unimom.Co. The 510(k) number is K232047.
When was VIVACE approved by the FDA?
VIVACE received FDA 510(k) clearance on 2024-03-28, under approval number K232047.
What company makes VIVACE?
VIVACE is manufactured by Unimom.Co.
What is the FDA product code for VIVACE?
The FDA product code for VIVACE is HGX.
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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.