← Product Code [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT) · K800243

# D668 & D664 CENTRAL MONITORING SYSTEMS (K800243)

_Medtel Pty. , Ltd. · DRT · Apr 10, 1980 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K800243

## Device Facts

- **Applicant:** Medtel Pty. , Ltd.
- **Product Code:** [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT.md)
- **Decision Date:** Apr 10, 1980
- **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/K800243](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K800243)

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