← Product Code [DRJ](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ) · K771685

# AMPLIFIER MODEL N5A-HIS (K771685)

_Honeywell, Inc. · DRJ · Sep 14, 1977 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ/K771685

## Device Facts

- **Applicant:** Honeywell, Inc.
- **Product Code:** [DRJ](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ.md)
- **Decision Date:** Sep 14, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2600
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Regulatory Identification

A signal isolation system is a device that electrically isolates the patient from equipment connected to the commercial power supply received from a utility company. This isolation may be accomplished, for example, by transformer coupling, acoustic coupling, or optical coupling.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ/K771685](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ/K771685)

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