FDA product code GZM: Analyzer, Rigidity
GZM is the FDA product code for analyzer, rigidity. It is a Class II device, regulated under 21 CFR 882.1020 and reviewed by the Neurology panel. Devices under GZM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Rigidity |
| Device class | Class II |
| Regulation | 21 CFR 882.1020 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for GZM devices
openFDA lists no recalls for product code GZM.
Frequently asked questions
What is FDA product code GZM?
GZM is the FDA product code for analyzer, rigidity. It is a Class II device, regulated under 21 CFR 882.1020 and reviewed by the Neurology panel.
What device class is GZM?
Class II, regulation 21 CFR 882.1020. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GZM
- Run a recall and safety report across every GZM manufacturer
- Watch product code GZM 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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