Product code
OLX: Source localization software for electroencephalograph or magnetoencephalograph
FDA product code · Class II · Neurology
Key facts
| Product code | OLX |
|---|---|
| Device | Source localization software for electroencephalograph or magnetoencephalograph |
| 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 | Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization |
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