PHZClass II
Abnormal Breath Sound Device
Anesthesiology · 21 CFR 868.1900
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
MDR events0All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances7All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Tyto Care , Ltd.Jun 2, 2026
K252844 · Tyto Insights for Wheeze Detection (with PCCP)
- Tyto Care , Ltd.Apr 7, 2025
K243567 · Tyto Insights for Rhonchi Detection
- Tyto Care , Ltd.Jul 2, 2024
K240555 · Tyto Insights for Crackles Detection
- Tyto Care , Ltd.Dec 13, 2023
K232237 · Tyto Insights for Wheeze Detection
- Tyto Care , Ltd.Feb 24, 2023
K221614 · TytoCare Lung Sounds Analyzer
- Respiri LimitedMar 11, 2021
K202062 · wheezo WheezeRate Detector
- Isonea, Ltd.Aug 19, 2014
K131285 · SONOSENTRY