Volnewmer
K-Number: K240248 · 2024-04-29
ApplicantClassys, Inc.
Decision Date2024-04-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Volnewmer is a medical device manufactured by Classys, Inc.. It received FDA 510(k) clearance on 2024-04-29 under approval number K240248. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Volnewmer?
Volnewmer is a medical device that received FDA 510(k) clearance on 2024-04-29. It is manufactured by Classys, Inc.. The 510(k) number is K240248.
When was Volnewmer approved by the FDA?
Volnewmer received FDA 510(k) clearance on 2024-04-29, under approval number K240248.
What company makes Volnewmer?
Volnewmer is manufactured by Classys, Inc..
What is the FDA product code for Volnewmer?
The FDA product code for Volnewmer is GEI.
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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.