FDA product code PFY: Low Patient Acuity Monitoring System
PFY is the FDA product code for low patient acuity monitoring system. It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel. Devices under PFY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.
Classification
| Field | Value |
|---|---|
| Device name | Low Patient Acuity Monitoring System |
| Device class | Class II |
| Regulation | 21 CFR 870.2300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for PFY devices
openFDA lists no recalls for product code PFY.
Frequently asked questions
What is FDA product code PFY?
PFY is the FDA product code for low patient acuity monitoring system. It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel.
What device class is PFY?
Class II, regulation 21 CFR 870.2300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PFY
- Run a recall and safety report across every PFY manufacturer
- Watch product code PFY 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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