DreaMed Advisor Pro is an AI-enabled medical device from DreaMed Diabetes Ltd, listed by FDA (510(k), K191370) with a decision date of 2019-07-18. Review panel: Clinical Chemistry.
| FDA submission number | K191370 |
|---|---|
| Pathway | 510(k) |
| Company | DreaMed Diabetes Ltd |
| Review panel (specialty) | Clinical Chemistry |
| FDA decision date | 2019-07-18 |
| Decision | Substantially Equivalent |
| Product code | QCC |
| Classification | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Device class | 2 |
| Regulation number | 862.1358 |
| Review time (calendar days) | 57 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
All Clinical Chemistry AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.