Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2640](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2640) → DSM — Alarm, Leakage Current, Portable

# DSM · Alarm, Leakage Current, Portable

_Cardiovascular · 21 CFR 870.2640 · Class 1_

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

## Overview

- **Product Code:** DSM
- **Device Name:** Alarm, Leakage Current, Portable
- **Regulation:** [21 CFR 870.2640](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2640)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A portable leakage current alarm is a device used to measure the electrical leakage current between any two points of an electrical system and to sound an alarm if the current exceeds a certain threshold.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K781152](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSM/K781152.md) | ELECTROCARDIOGRAPHIC ECG RECORDER | Cardio-Dynamics Laboratories, Inc. | Aug 31, 1978 | SESE |

## Top Applicants

- Cardio-Dynamics Laboratories, Inc. — 1 clearance

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

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