FDA product code JXF: Plethysmograph, Ocular
JXF is the FDA product code for plethysmograph, ocular. It is a Class III device, regulated under 21 CFR 882.1790 and reviewed by the Neurology panel. Devices under JXF reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
PMAs to be filed by 9/21/04 (69 FR 34920 (6/23/04))
Classification
| Field | Value |
|---|---|
| Device name | Plethysmograph, Ocular |
| Device class | Class III |
| Regulation | 21 CFR 882.1790 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | PMA |
Recalls for JXF devices
openFDA lists no recalls for product code JXF.
Frequently asked questions
What is FDA product code JXF?
JXF is the FDA product code for plethysmograph, ocular. It is a Class III device, regulated under 21 CFR 882.1790 and reviewed by the Neurology panel.
What device class is JXF?
Class III, regulation 21 CFR 882.1790. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code JXF
- Run a recall and safety report across every JXF manufacturer
- Watch product code JXF 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.