PHZ
- Product code
- PHZ
- Device name
- Abnormal Breath Sound Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1900
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
FDA classification definition
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252844 | 2026-06-02 | Tyto Care , Ltd. | Tyto Insights for Wheeze Detection (with PCCP) | |
| K243567 | 2025-04-07 | Tyto Care , Ltd. | Tyto Insights for Rhonchi Detection | |
| K240555 | 2024-07-02 | Tyto Care , Ltd. | Tyto Insights for Crackles Detection | |
| K232237 | 2023-12-13 | Tyto Care , Ltd. | Tyto Insights for Wheeze Detection |
Official FDA classification page: PHZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).