Tyto Insights for Wheeze Detection is an AI-enabled medical device from Tyto Care Ltd., listed by FDA (510(k), K232237) with a decision date of 2023-12-13. Review panel: Anesthesiology.
| FDA submission number | K232237 |
|---|---|
| Pathway | 510(k) |
| Company | Tyto Care Ltd. |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2023-12-13 |
| Decision | Substantially Equivalent |
| Product code | PHZ |
| Classification | Abnormal Breath Sound Device |
| Device class | 2 |
| Regulation number | 868.1900 |
| Review time (calendar days) | 138 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.