Bunkerhill AVC
K-Number: K243229 · 2025-01-27
ApplicantBunkerHill Health
Decision Date2025-01-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Bunkerhill AVC is a medical device manufactured by BunkerHill Health. It received FDA 510(k) clearance on 2025-01-27 under approval number K243229. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bunkerhill AVC?
Bunkerhill AVC is a medical device that received FDA 510(k) clearance on 2025-01-27. It is manufactured by BunkerHill Health. The 510(k) number is K243229.
When was Bunkerhill AVC approved by the FDA?
Bunkerhill AVC received FDA 510(k) clearance on 2025-01-27, under approval number K243229.
What company makes Bunkerhill AVC?
Bunkerhill AVC is manufactured by BunkerHill Health.
What is the FDA product code for Bunkerhill AVC?
The FDA product code for Bunkerhill AVC is JAK.
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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.