FDA product code EXZ: Equipment, Photographic, For Physiologic Function Monitor
EXZ is the FDA product code for equipment, photographic, for physiologic function monitor. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under EXZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Equipment, Photographic, For Physiologic Function Monitor |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for EXZ devices
openFDA lists no recalls for product code EXZ.
Frequently asked questions
What is FDA product code EXZ?
EXZ is the FDA product code for equipment, photographic, for physiologic function monitor. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is EXZ?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EXZ
- Run a recall and safety report across every EXZ manufacturer
- Watch product code EXZ 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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