Product code
QBE: Cranial sound monitor
FDA product code · Class II · Neurology
Key facts
| Product code | QBE |
|---|---|
| Device | Cranial sound monitor |
| Device class | Class II |
| Regulation number | 870.1875 |
| Review panel | Neurology |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To non-invasively detect, monitor, record and display acoustic signals in the brain. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None 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