Masimo SafetyNet is an AI-enabled medical device from Masimo Corporation, listed by FDA (De Novo, DEN200011) with a decision date of 2023-03-31. Review panel: Anesthesiology.
| FDA submission number | DEN200011 |
|---|---|
| Pathway | De Novo |
| Company | Masimo Corporation |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2023-03-31 |
| Decision | Unknown |
| Product code | QVT |
| Classification | Monitor For Opioid Induced Impairment Of Oxygenation |
| Device class | 2 |
| Regulation number | 868.2250 |
| Review time (calendar days) | 1136 |
| Applicant country | US |
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.