PMD-200 is an AI-enabled medical device from Medasense Biometrics Ltd., listed by FDA (De Novo, DEN210022) with a decision date of 2023-02-17. Review panel: Anesthesiology.
| FDA submission number | DEN210022 |
|---|---|
| Pathway | De Novo |
| Company | Medasense Biometrics Ltd. |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2023-02-17 |
| Decision | Unknown |
| Product code | QVE |
| Classification | Adjunctive Pain Measurement Device For Anesthesiology |
| Device class | 2 |
| Regulation number | 868.2200 |
| Review time (calendar days) | 623 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
All Anesthesiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.