encevis (2.1) is an AI-enabled medical device from AIT Austrian Institute of Technology GmbH, listed by FDA (510(k), K240993) with a decision date of 2024-09-27. Review panel: Neurology.
| FDA submission number | K240993 |
|---|---|
| Pathway | 510(k) |
| Company | AIT Austrian Institute of Technology GmbH |
| Review panel (specialty) | Neurology |
| FDA decision date | 2024-09-27 |
| Decision | Substantially Equivalent |
| Product code | OMB |
| Classification | Automatic Event Detection Software For Full-Montage Electroencephalograph |
| Device class | 2 |
| Regulation number | 882.1400 |
| Review time (calendar days) | 169 |
| Applicant country | AT |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.