Tyto Care , Ltd.
FDA 510(k) & PMA Approved Devices — 9 products
Total Devices9
Categories3
Latest FDA decision2026-06-02
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252844 | Tyto Insights for Wheeze Detection (with PCCP) | PHZ | 2026-06-02 | View |
| 510(k) | K252089 | Tyto Stethoscope (G3) | DQD | 2026-03-12 | View |
| 510(k) | K243567 | Tyto Insights for Rhonchi Detection | PHZ | 2025-04-07 | View |
| 510(k) | K240555 | Tyto Insights for Crackles Detection | PHZ | 2024-07-02 | View |
| 510(k) | K232237 | Tyto Insights for Wheeze Detection | PHZ | 2023-12-13 | View |
| 510(k) | K221614 | TytoCare Lung Sounds Analyzer | PHZ | 2023-02-24 | View |
| 510(k) | K190242 | Tyto Thermometer | FLL | 2019-03-27 | View |
| 510(k) | K181612 | Tyto Stethoscope (OTC) | DQD | 2018-12-17 | View |
| 510(k) | K160401 | Tyto Stethoscope | DQD | 2016-10-19 | View |
No matching devices.