PFY

Low Patient Acuity Monitoring System

Product code
PFY
Device name
Low Patient Acuity Monitoring System
Device class
Class 2
21 CFR
21 CFR 870.2300
Medical specialty
Cardiovascular
Marketing pathway
510(K)

FDA classification definition

For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PFY
Classification and pathway per current FDA publications. Data from openFDA (CC0).