FDA product code PGJ: Oximeter, Wellness
PGJ is the FDA product code for oximeter, wellness. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Anesthesiology panel. Devices under PGJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Pulse oximeter intended for wellness use.
Classification
| Field | Value |
|---|---|
| Device name | Oximeter, Wellness |
| Device class | Class II |
| Regulation | 21 CFR 870.2700 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for PGJ devices
openFDA lists no recalls for product code PGJ.
Frequently asked questions
What is FDA product code PGJ?
PGJ is the FDA product code for oximeter, wellness. It is a Class II device, regulated under 21 CFR 870.2700 and reviewed by the Anesthesiology panel.
What device class is PGJ?
Class II, regulation 21 CFR 870.2700. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PGJ
- Run a recall and safety report across every PGJ manufacturer
- Watch product code PGJ 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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