FDA product code GXS: Monitor, Alpha
GXS is the FDA product code for monitor, alpha. It is a Class II device, regulated under 21 CFR 882.1610 and reviewed by the Neurology panel. Devices under GXS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Alpha |
| Device class | Class II |
| Regulation | 21 CFR 882.1610 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GXS devices
openFDA lists no recalls for product code GXS.
Frequently asked questions
What is FDA product code GXS?
GXS is the FDA product code for monitor, alpha. It is a Class II device, regulated under 21 CFR 882.1610 and reviewed by the Neurology panel.
What device class is GXS?
Class II, regulation 21 CFR 882.1610. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GXS
- Run a recall and safety report across every GXS manufacturer
- Watch product code GXS 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.