FDA Product Code
FDA Product Code PHZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.1900
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260140 | Aevice Wheeze Detection Module | Aevice Health Pte. , Ltd. | 2026-09-25 | Traditional | PDF ↗ |
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | 2026-06-02 | Traditional | PDF ↗ |
| K243567 | Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. | 2025-04-07 | Traditional | PDF ↗ |
| K240555 | Tyto Insights for Crackles Detection | Tyto Care , Ltd. | 2024-07-02 | Traditional | PDF ↗ |
| K232237 | Tyto Insights for Wheeze Detection | Tyto Care , Ltd. | 2023-12-13 | Traditional | PDF ↗ |
| K221614 | TytoCare Lung Sounds Analyzer | Tyto Care , Ltd. | 2023-02-24 | Traditional | PDF ↗ |
| K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021-03-11 | Traditional | PDF ↗ |
| K131285 | SONOSENTRY | Isonea, Ltd. | 2014-08-19 | Traditional | PDF ↗ |
Product code PHZ · Class II · Anesthesiology. Data: openFDA.