CLEWICU System is an AI-enabled medical device from Clew Medical Ltd., listed by FDA (510(k), K233216) with a decision date of 2024-01-13. Review panel: Cardiovascular.
| FDA submission number | K233216 |
|---|---|
| Pathway | 510(k) |
| Company | Clew Medical Ltd. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2024-01-13 |
| Decision | Substantially Equivalent |
| Product code | QNL |
| Classification | Medium-Term Adjunctive Predictive Cardiovascular Indicator |
| Device class | 2 |
| Regulation number | 870.2210 |
| Review time (calendar days) | 107 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.