Cardiac Guidance— 510(k) K243065
Substantially EquivalentCaption Health, Inc.
FDA 510(k) clearance K243065 for Cardiac Guidance, Substantially Equivalent on 2025-01-15. Applicant: Caption Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Caption Health, Inc.
- Product code
- Code QJU
- Device class
- Class 2
- Regulation
- 21 CFR 892.2100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Mateo, CA, US
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