FDA product code JEZ: Monitor, Lung Water Measurement
JEZ is the FDA product code for monitor, lung water measurement. It is a Class III device, regulated under 21 CFR 868.2450 and reviewed by the Anesthesiology panel. Devices under JEZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Lung Water Measurement |
| Device class | Class III |
| Regulation | 21 CFR 868.2450 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | PMA |
Recalls for JEZ devices
openFDA lists no recalls for product code JEZ.
Frequently asked questions
What is FDA product code JEZ?
JEZ is the FDA product code for monitor, lung water measurement. It is a Class III device, regulated under 21 CFR 868.2450 and reviewed by the Anesthesiology panel.
What device class is JEZ?
Class III, regulation 21 CFR 868.2450. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code JEZ
- Run a recall and safety report across every JEZ manufacturer
- Watch product code JEZ 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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