Cardiac Guidance
K-Number: K243065 · 2025-01-15
ApplicantCaption Health, Inc.
Decision Date2025-01-15
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Cardiac Guidance is a medical device manufactured by Caption Health, Inc.. It received FDA 510(k) clearance on 2025-01-15 under approval number K243065. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cardiac Guidance?
Cardiac Guidance is a medical device that received FDA 510(k) clearance on 2025-01-15. It is manufactured by Caption Health, Inc.. The 510(k) number is K243065.
When was Cardiac Guidance approved by the FDA?
Cardiac Guidance received FDA 510(k) clearance on 2025-01-15, under approval number K243065.
What company makes Cardiac Guidance?
Cardiac Guidance is manufactured by Caption Health, Inc..
What is the FDA product code for Cardiac Guidance?
The FDA product code for Cardiac Guidance is QJU.
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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.