Stethee Pro 1, Stethee Pro Software System is an AI-enabled medical device from M3DICINE Pty Ltd., listed by FDA (510(k), K193631) with a decision date of 2020-10-09. Review panel: Cardiovascular.
| FDA submission number | K193631 |
|---|---|
| Pathway | 510(k) |
| Company | M3DICINE Pty Ltd. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2020-10-09 |
| Decision | Substantially Equivalent |
| Product code | DQD |
| Classification | Stethoscope, Electronic |
| Device class | 2 |
| Regulation number | 870.1875 |
| Review time (calendar days) | 287 |
| Applicant country | AU |
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.