FDA product code JEF: Analyzer, Gas, Neon, Gaseous-Phase
JEF is the FDA product code for analyzer, gas, neon, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1670 and reviewed by the Anesthesiology panel. Devices under JEF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Neon, Gaseous-Phase |
| Device class | Class II |
| Regulation | 21 CFR 868.1670 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JEF devices
openFDA lists no recalls for product code JEF.
Frequently asked questions
What is FDA product code JEF?
JEF is the FDA product code for analyzer, gas, neon, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1670 and reviewed by the Anesthesiology panel.
What device class is JEF?
Class II, regulation 21 CFR 868.1670. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JEF
- Run a recall and safety report across every JEF manufacturer
- Watch product code JEF 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.