Bunkerhill MAC
K-Number: K250662 · 2025-10-03
ApplicantBunkerHill Health
Decision Date2025-10-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Bunkerhill MAC is a medical device manufactured by BunkerHill Health. It received FDA 510(k) clearance on 2025-10-03 under approval number K250662. 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 MAC?
Bunkerhill MAC is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by BunkerHill Health. The 510(k) number is K250662.
When was Bunkerhill MAC approved by the FDA?
Bunkerhill MAC received FDA 510(k) clearance on 2025-10-03, under approval number K250662.
What company makes Bunkerhill MAC?
Bunkerhill MAC is manufactured by BunkerHill Health.
What is the FDA product code for Bunkerhill MAC?
The FDA product code for Bunkerhill MAC 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.