← Product Code [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH) · K880283

# PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS (K880283)

_Paceart, Inc. · DXH · Mar 9, 1988 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K880283

## Device Facts

- **Applicant:** Paceart, Inc.
- **Product Code:** [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH.md)
- **Decision Date:** Mar 9, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2920
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K880283](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K880283)

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