CaRi-Heart— 510(k) DEN250042
UnknownCaristo Diagnostics , Ltd.
FDA 510(k) clearance DEN250042 for CaRi-Heart, Unknown on 2026-07-28. Applicant: Caristo Diagnostics , Ltd.. Device class: 2.
Summary
CaRi-Heart from Caristo Diagnostics is filed under SIU, predictive indicators for long-term cardiovascular outcomes. The record doesn't describe the product's inputs or what it reports.
Class II, 21 CFR 870.2215. Cardiovascular is both the classification panel and the review panel. The record lists the submission type as Direct.
Caristo Diagnostics filed from Stamford, Connecticut. The decision date came 327 calendar days after the received date (September 4, 2025 to July 28, 2026).
Clearance details
- Applicant
- Caristo Diagnostics , Ltd.
- Product code
- Product code SIU
- Device class
- Class 2
- Regulation
- 21 CFR 870.2215
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Stamford, CT, US
More clearances from Caristo Diagnostics , Ltd.
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