Decision Date2025-04-25
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
butterflyBVM is a medical device manufactured by Compact Medical, Inc.. It received FDA 510(k) clearance on 2025-04-25 under approval number K243861. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the butterflyBVM?
butterflyBVM is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Compact Medical, Inc.. The 510(k) number is K243861.
When was butterflyBVM approved by the FDA?
butterflyBVM received FDA 510(k) clearance on 2025-04-25, under approval number K243861.
What company makes butterflyBVM?
butterflyBVM is manufactured by Compact Medical, Inc..
What is the FDA product code for butterflyBVM?
The FDA product code for butterflyBVM is BTM.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.