Product code QBE
- Device name
- Cranial Sound Monitor
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1875
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To non-invasively detect, monitor, record and display acoustic signals in the brain.
- Source
- FDA openFDA device classification dataset