Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2300](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2300) → PFY — Low Patient Acuity Monitoring System

# PFY · Low Patient Acuity Monitoring System

_Cardiovascular · 21 CFR 870.2300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/PFY

## Overview

- **Product Code:** PFY
- **Device Name:** Low Patient Acuity Monitoring System
- **Regulation:** [21 CFR 870.2300](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2300)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/PFY](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/PFY)

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