FibriCheck is an AI-enabled medical device from Qompium nv, listed by FDA (510(k), K173872) with a decision date of 2018-09-28. Review panel: Cardiovascular.
| FDA submission number | K173872 |
|---|---|
| Pathway | 510(k) |
| Company | Qompium nv |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2018-09-28 |
| Decision | Substantially Equivalent |
| Product code | DXH |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | 2 |
| Regulation number | 870.2920 |
| Review time (calendar days) | 282 |
| Applicant country | BE |
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.