Cardiac Guidance— 510(k) K243065

Substantially Equivalent

Caption Health, Inc.

FDA 510(k) clearance K243065 for Cardiac Guidance, Substantially Equivalent on 2025-01-15. Applicant: Caption Health, Inc..

Clearance details

Applicant: Caption Health, Inc.
Product code: Code QJU
Advisory panel: Radiology
Date received: 2024-09-27
Decision date: 2025-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

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