← Product Code [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT) · K850407

# NEONATAL MONITOR 309 (K850407)

_Rigel Medical Electronics, Inc. · DRT · Apr 18, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K850407

## Device Facts

- **Applicant:** Rigel Medical Electronics, Inc.
- **Product Code:** [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT.md)
- **Decision Date:** Apr 18, 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/K850407](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K850407)

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