FDA product code GZN: Rheoencephalograph
GZN is the FDA product code for rheoencephalograph. It is a Class III device, regulated under 21 CFR 882.1825 and reviewed by the Neurology panel. Devices under GZN reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Rheoencephalograph |
| Device class | Class III |
| Regulation | 21 CFR 882.1825 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | PMA |
Recalls for GZN devices
openFDA lists no recalls for product code GZN.
Frequently asked questions
What is FDA product code GZN?
GZN is the FDA product code for rheoencephalograph. It is a Class III device, regulated under 21 CFR 882.1825 and reviewed by the Neurology panel.
What device class is GZN?
Class III, regulation 21 CFR 882.1825. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code GZN
- Run a recall and safety report across every GZN manufacturer
- Watch product code GZN 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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