FDA Product Code
FDA Product Code SIU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2215
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN250042 | CaRi-Heart | Caristo Diagnostics , Ltd. | 2026-07-28 | Direct | — |
Product code SIU · Class II · Cardiovascular. Data: openFDA.