CaRi-Heart
FDA 510(k) clearance DEN250042 · decided 2026-07-28
Clearance details
- K-number
- DEN250042
- Device name
- CaRi-Heart
- Applicant
- Caristo Diagnostics , Ltd.
- Decision
- Unknown
- Date received
- 2025-09-04
- Decision date
- 2026-07-28
- Days to decision
- 327 days
- Clearance type
- Direct
- Product code
- SIU
- Device class
- 2
- Regulation number
- 870.2215
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Stamford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.