← Product Code [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT) · K910665

# MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED (K910665)

_Ge Medical Systems Information Technologies · DRT · Dec 31, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K910665

## Device Facts

- **Applicant:** Ge Medical Systems Information Technologies
- **Product Code:** [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT.md)
- **Decision Date:** Dec 31, 1991
- **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/K910665](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K910665)

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