← Product Code [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT) · K910870

# EDENTEC MODEL 3711 DIGITAL RECORDER (K910870)

_Edentec Corp. · DRT · Aug 29, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K910870

## Device Facts

- **Applicant:** Edentec Corp.
- **Product Code:** [DRT](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT.md)
- **Decision Date:** Aug 29, 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/K910870](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRT/K910870)

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