Dreem 3S is an AI-enabled medical device from Beacon Biosignals, Inc., listed by FDA (510(k), K223539) with a decision date of 2023-08-18. Review panel: Neurology.
| FDA submission number | K223539 |
|---|---|
| Pathway | 510(k) |
| Company | Beacon Biosignals, Inc. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2023-08-18 |
| Decision | Substantially Equivalent |
| Product code | OLZ |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Device class | 2 |
| Regulation number | 882.1400 |
| Review time (calendar days) | 268 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Beacon Biosignals, Inc. · All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.