CAC (gated) Algorithm
K-Number: K240369 · 2024-09-27
ApplicantBunkerHill Health
Decision Date2024-09-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CAC (gated) Algorithm is a medical device manufactured by BunkerHill Health. It received FDA 510(k) clearance on 2024-09-27 under approval number K240369. 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 CAC (gated) Algorithm?
CAC (gated) Algorithm is a medical device that received FDA 510(k) clearance on 2024-09-27. It is manufactured by BunkerHill Health. The 510(k) number is K240369.
When was CAC (gated) Algorithm approved by the FDA?
CAC (gated) Algorithm received FDA 510(k) clearance on 2024-09-27, under approval number K240369.
What company makes CAC (gated) Algorithm?
CAC (gated) Algorithm is manufactured by BunkerHill Health.
What is the FDA product code for CAC (gated) Algorithm?
The FDA product code for CAC (gated) Algorithm 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.