Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2340](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2340) → MLC — Monitor, St Segment

# MLC · Monitor, St Segment

_Cardiovascular · 21 CFR 870.2340 · Class 2_

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

## Overview

- **Product Code:** MLC
- **Device Name:** Monitor, St Segment
- **Regulation:** [21 CFR 870.2340](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2340)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K993826](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLC/K993826.md) | NARKOMED 6000 | Draeger Medical, Inc. | Mar 23, 2000 | SESE |
| [K926099](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MLC/K926099.md) | DATASCOPE 6000 MONITOR | Datascope Corp. | Aug 6, 1993 | SESE |

## Top Applicants

- Datascope Corp. — 1 clearance
- Draeger Medical, Inc. — 1 clearance

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

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