NEVISENSE is an AI-enabled medical device from SCIBASE AB, listed by FDA (PMA, P150046) with a decision date of 2017-06-28. Review panel: General and Plastic Surgery.
| FDA submission number | P150046 |
|---|---|
| Pathway | PMA |
| Company | SCIBASE AB |
| Review panel (specialty) | General and Plastic Surgery |
| FDA decision date | 2017-06-28 |
| Product code | ONV |
| Classification | Electrical Impedance Spectrometer |
| Device class | 2 |
| Regulation number | 878.1820 |
| Review time (calendar days) | 569 |
Official FDA database record · FDA AI-enabled device list
All General and Plastic Surgery AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.