Product code PHZ
- Device name
- Abnormal Breath Sound Device
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1900
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
- Source
- FDA openFDA device classification dataset