4 devices · 2 companies · 2023 to 2026
Product code PHZ: Abnormal Breath Sound Device
4 devices under product code PHZ, 2023 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Abnormal Breath Sound Device. 21 CFR 868.1900, Class II. The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Tyto Insights for Wheeze DetectionK252844 · 510(k) | Tyto Care , Ltd. | Anesthesiology | database entry | |
| Tyto Insights for Rhonchi DetectionK243567 · 510(k) | Tyto Care , Ltd. | Anesthesiology | database entry | |
| Tyto Insights for Crackles DetectionK240555 · 510(k) | Tyto Care Ltd. | Anesthesiology | database entry | |
| Tyto Insights for Wheeze DetectionK232237 · 510(k) | Tyto Care Ltd. | Anesthesiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.