Tyto Insights for Crackles Detection is an AI-enabled medical device from Tyto Care Ltd., listed by FDA (510(k), K240555) with a decision date of 2024-07-02. Review panel: Anesthesiology.
| FDA submission number | K240555 |
|---|---|
| Pathway | 510(k) |
| Company | Tyto Care Ltd. |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2024-07-02 |
| Decision | Substantially Equivalent |
| Product code | PHZ |
| Classification | Abnormal Breath Sound Device |
| Device class | 2 |
| Regulation number | 868.1900 |
| Review time (calendar days) | 125 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
More devices from Tyto Care Ltd. · All Anesthesiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.