Biovitals Analytics Engine is an AI-enabled medical device from Biofourmis Singapore Pte. Ltd, listed by FDA (510(k), K183282) with a decision date of 2019-08-15. Review panel: Cardiovascular.
| FDA submission number | K183282 |
|---|---|
| Pathway | 510(k) |
| Company | Biofourmis Singapore Pte. Ltd |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2019-08-15 |
| Decision | Substantially Equivalent |
| Product code | PLB |
| Classification | Multivariate Vital Signs Index |
| Device class | 2 |
| Regulation number | 870.2300 |
| Review time (calendar days) | 262 |
| Applicant country | SG |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.