FDA product code JEG: Analyzer, Gas, Argon, Gaseous-Phase
JEG is the FDA product code for analyzer, gas, argon, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1075 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under JEG. The average 510(k) review took 104 days (median 104).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Argon, Gaseous-Phase |
| Device class | Class II |
| Regulation | 21 CFR 868.1075 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JEG clearance
Top JEG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pro Care Laboratories, Inc. | 1 | 1988-05-16 |
Most recent JEG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880442 | Pro Care Laboratories, Inc. | BRUSHRITE | 1988-05-16 | 104 |
Recalls for JEG devices
openFDA lists no recalls for product code JEG.
Frequently asked questions
What is FDA product code JEG?
JEG is the FDA product code for analyzer, gas, argon, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1075 and reviewed by the Anesthesiology panel.
What device class is JEG?
Class II, regulation 21 CFR 868.1075. Typical premarket route: 510(k).
How long does a 510(k) take for product code JEG?
Across 1 cleared submissions the average was 104 days from receipt to decision (median 104).
Which companies have the most JEG clearances?
Pro Care Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JEG
- Run a recall and safety report across every JEG manufacturer
- Watch product code JEG 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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