Product code
OAQ: Electronic media, hyperacusis
FDA product code · Not Classified · Ear Nose & Throat
Key facts
| Product code | OAQ |
|---|---|
| Device | Electronic media, hyperacusis |
| Device class | Not Classified |
| Review panel | Ear Nose & Throat |
| Submission type | Enforcement Discretion |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To improve sound tolerances. |
At a glance
- None 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