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.
Clearance details
- Applicant
- Caristo Diagnostics , Ltd.
- Product code
- 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
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