PHZ · Abnormal Breath Sound Device
Anesthesiology · 21 CFR 868.1900 · Class 2
Overview
| Product Code | PHZ |
|---|---|
| Device Name | Abnormal Breath Sound Device |
| Regulation | 21 CFR 868.1900 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.
Classification Rationale
Class II (performance standards).
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243567 | Tyto Insights for Rhonchi Detection | Tyto Care , Ltd. | Apr 7, 2025 | SESE |
| K240555 | Tyto Insights for Crackles Detection | Tyto Care , Ltd. | Jul 2, 2024 | SESE |
| K232237 | Tyto Insights for Wheeze Detection | Tyto Care , Ltd. | Dec 13, 2023 | SESE |
| K221614 | TytoCare Lung Sounds Analyzer | Tyto Care , Ltd. | Feb 24, 2023 | SESE |
| K202062 | wheezo WheezeRate Detector | Respiri Limited | Mar 11, 2021 | SESE |
| K131285 | SONOSENTRY | Isonea, Ltd. | Aug 19, 2014 | SESE |
Top Applicants
- Tyto Care , Ltd. — 4 clearances
- Respiri Limited — 1 clearance
- Isonea, Ltd. — 1 clearance
