Falcon HST is an AI-enabled medical device from Compumedics Limited, listed by FDA (510(k), K242447) with a decision date of 2025-02-20. Review panel: Neurology.
| FDA submission number | K242447 |
|---|---|
| Pathway | 510(k) |
| Company | Compumedics Limited |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-02-20 |
| Decision | Substantially Equivalent |
| Product code | OLV |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Device class | 2 |
| Regulation number | 882.1400 |
| Review time (calendar days) | 188 |
| Applicant country | AU |
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.