Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2600](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2600) → DRJ — System, Signal Isolation

# DRJ · System, Signal Isolation

_Cardiovascular · 21 CFR 870.2600 · Class 1_

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

## Overview

- **Product Code:** DRJ
- **Device Name:** System, Signal Isolation
- **Regulation:** [21 CFR 870.2600](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2600)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K832828](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ/K832828.md) | CENTURION CARDIAC DETECTOR | Clinical Data Instruments, Inc. | May 9, 1984 | SESE |
| [K822590](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ/K822590.md) | PRESSURE ISOLATION AMPLIFIER #9813 517 | Honeywell, Inc. | Oct 4, 1982 | SESE |
| [K771685](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ/K771685.md) | AMPLIFIER MODEL N5A-HIS | Honeywell, Inc. | Sep 14, 1977 | SESE |
| [K771684](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRJ/K771684.md) | AMPLIFIER MODEL N5A-ECG | Honeywell, Inc. | Sep 14, 1977 | SESE |

## Top Applicants

- Honeywell, Inc. — 3 clearances
- Clinical Data Instruments, Inc. — 1 clearance

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

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