Product code
OLU: Normalizing quantitative electroencephalograph software
FDA product code · Class II · Neurology
Key facts
| Product code | OLU |
|---|---|
| Device | Normalizing quantitative electroencephalograph software |
| Device class | Class II |
| Regulation number | 882.1400 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database