Panels › Anesthesiology › Product code PHZ · Class 2
Abnormal Breath Sound Device
Regulation 868.1900
2510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PHZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Tyto Care , Ltd. | 5 | 0 |
| Aevice Health Pte. , Ltd. | 1 | 0 |
| Isonea, Ltd. | 1 | 0 |
| Respiri Limited | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2026 | K260140 | Aevice Wheeze Detection Module Aevice Health Pte. , Ltd., SG | PHZ |
| Jun 2, 2026 | K252844 | Tyto Insights for Wheeze Detection (with PCCP) Tyto Care , Ltd., IL | PHZ |
| Apr 7, 2025 | K243567 | Tyto Insights for Rhonchi Detection Tyto Care , Ltd., IL | PHZ |
| Jul 2, 2024 | K240555 | Tyto Insights for Crackles Detection Tyto Care , Ltd., IL | PHZ |
| Dec 13, 2023 | K232237 | Tyto Insights for Wheeze Detection Tyto Care , Ltd., IL | PHZ |
| Feb 24, 2023 | K221614 | TytoCare Lung Sounds Analyzer Tyto Care , Ltd., IL | PHZ |
| Mar 11, 2021 | K202062 | wheezo WheezeRate Detector Respiri Limited, AU | PHZ |
| Aug 19, 2014 | K131285 | SONOSENTRY Isonea, Ltd. | PHZ |
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