Product code
PIW: Brain injury adjunctive interpretive electroencephalograph assessment aid
FDA product code · Class II · Neurology
Key facts
| Product code | PIW |
|---|---|
| Device | Brain injury adjunctive interpretive electroencephalograph assessment aid |
| Device class | Class II |
| Regulation number | 882.1450 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 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