Product code
GWQ: Full-montage standard electroencephalograph
FDA product code · Class II · Neurology
Key facts
| Product code | GWQ |
|---|---|
| Device | Full-montage standard electroencephalograph |
| 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 | Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations |
At a glance
- 100–999 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 10–99 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