← Product Code [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS) · K853979

# CARDIMAX FX-1164 (K853979)

_Brentwood Instruments, Inc. · DPS · Feb 6, 1986 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K853979

## Device Facts

- **Applicant:** Brentwood Instruments, Inc.
- **Product Code:** [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS.md)
- **Decision Date:** Feb 6, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2340
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K853979](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K853979)

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