Steth IO is an AI-enabled medical device from STRATOSCIENTIFIC, INC., listed by FDA (510(k), K160016) with a decision date of 2016-07-15. Review panel: Cardiovascular.
| FDA submission number | K160016 |
|---|---|
| Pathway | 510(k) |
| Company | STRATOSCIENTIFIC, INC. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2016-07-15 |
| Decision | Substantially Equivalent |
| Product code | DQD |
| Classification | Stethoscope, Electronic |
| Device class | 2 |
| Regulation number | 870.1875 |
| Review time (calendar days) | 192 |
| Applicant country | US |
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.