← Product Code [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT) · K853673

# CARDIORATER CR 51 (K853673)

_Cardiac Recorders, Ltd. · DRT · Dec 11, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K853673

## Device Facts

- **Applicant:** Cardiac Recorders, Ltd.
- **Product Code:** [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT.md)
- **Decision Date:** Dec 11, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2300
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K853673](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K853673)

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