Product code PRK
- Device name
- Device Indicating An Exhalation Event
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2375
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- To provide visual indication of each exhalation event
- Source
- FDA openFDA device classification dataset