FDA product code JEO: Measurer, Gingival Fluid
JEO is the FDA product code for measurer, gingival fluid. It is a Class I device, regulated under 21 CFR 872.1500 and reviewed by the Dental panel. Devices under JEO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Measurer, Gingival Fluid |
| Device class | Class I |
| Regulation | 21 CFR 872.1500 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for JEO devices
openFDA lists no recalls for product code JEO.
Frequently asked questions
What is FDA product code JEO?
JEO is the FDA product code for measurer, gingival fluid. It is a Class I device, regulated under 21 CFR 872.1500 and reviewed by the Dental panel.
What device class is JEO?
Class I, regulation 21 CFR 872.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JEO
- Run a recall and safety report across every JEO manufacturer
- Watch product code JEO 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.