PFY · Low Patient Acuity Monitoring System
Cardiovascular · 21 CFR 870.2300 · Class 2
Overview
| Product Code | PFY |
|---|---|
| Device Name | Low Patient Acuity Monitoring System |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
