FDA product code GWR: Generator, Electroencephalograph Test Signal
GWR is the FDA product code for generator, electroencephalograph test signal. It is a Class I device, regulated under 21 CFR 882.1430 and reviewed by the Neurology panel. Devices under GWR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Generator, Electroencephalograph Test Signal |
| Device class | Class I |
| Regulation | 21 CFR 882.1430 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for GWR devices
openFDA lists no recalls for product code GWR.
Frequently asked questions
What is FDA product code GWR?
GWR is the FDA product code for generator, electroencephalograph test signal. It is a Class I device, regulated under 21 CFR 882.1430 and reviewed by the Neurology panel.
What device class is GWR?
Class I, regulation 21 CFR 882.1430. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GWR
- Run a recall and safety report across every GWR manufacturer
- Watch product code GWR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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