DEN250042
- 510(k) number
- DEN250042
- Device name
- CaRi-Heart
- Applicant
- Caristo Diagnostics , Ltd. CT · US
- Product code
- SIU — Predictive Indicator For Long-Term Cardiovascular Ou
- Decision date
- 2026-07-28
- Date received
- 2025-09-04
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN250042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.