Product code OLU
- Device name
- Normalizing Quantitative Electroencephalograph Software
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1400
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
- Source
- FDA openFDA device classification dataset