← Product Code [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH) · K963375

# CARDIACMONITOR (K963375)

_Vision Electronics · DXH · Feb 28, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K963375

## Device Facts

- **Applicant:** Vision Electronics
- **Product Code:** [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH.md)
- **Decision Date:** Feb 28, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2920
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace.

## Device Story

External ambulatory ECG looping memory monitor; credit-card size (0.31" thick). Patient-activated during transient symptoms; records 90s ECG (continuous or 30s pre-/60s post-symptom). Data stored in looping memory; transferred via acoustic signal through standard telephone lines to receiving center. Used in home/workplace; operated by patient. Physician reviews transmitted ECG to diagnose cardiac events. Benefits: enables remote capture of transient arrhythmias without continuous clinical monitoring.

## Clinical Evidence

Bench testing only. Compliance with AAMI EC-13 and EC-38 standards for ECG monitoring equipment confirmed; results within allowable limits.

## Technological Characteristics

Non-invasive ambulatory ECG looping memory monitor. Dimensions: credit-card size, 0.31" thick. Connectivity: acoustic transmission via standard telephone lines. Power: internal battery (implied). Standards: AAMI EC-13, AAMI EC-38. Interface: slide switch for mode selection (P/P.P.), record button, erase button, internal speaker for acoustic data transmission.

## 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.

## Predicate Devices

- HeartCard ([K963375](/device/K963375.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

Page 6a.
K963375
FEB 28 1997

# SUMMARY OF STATEMENT OF SAFETY AND EFFECTIVENESS

CardiacMonitor - Cardiac Event Recorder

L. A. Wood Electronics, Inc.

Ref: K963375

The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace. The recorded ECG is sent by an acoustic signal from an internal speaker, using standard telephone lines to a telephonic receiver. The CardiacMonitor is the size of a Credit-card by about 0.31" thick.

The device records either a 90 second ECG when Physician set in the (P.) mode or a 30 second pre-symptom and a 60 second post-symptom for a 90 second total ECG when Physician set in the (P.P.) mode. The function of the (P.) or (P.P.) mode have no impact on the quality of the ECG data obtained. The CardiacMonitor Shares much of the same operating features as the predicate device, HeartCard and the technical specifications comparison reveal no substantial differences and no differences which would effect safety and effectiveness. The indications for use are the same.

A leadset provides means for attachment to standard ECG electrodes. Moving the slide switch to the (P.P.) mode activates the ECG scanning operation, during which ECG data is being stored in a looping memory. The memory loop continues to fill with the most recent ECG data. When the RECORD button is activated, the looping memory content is in non-looping memory.

The data stored in memory may be sent by the patient to a receiving center. The patient calls the center and when instructed places the mouthpiece of the telephone over the yellow circle on the monitor and presses and releases the telephone mouthpiece. The ECG data is sent over the phone lines via an acoustic signal. The data may be sent again if requested. The stored data is retained until the "Erase" button is pressed.

AAMI EC-13 and EC-38 test data results are all within the minimum and maximum allowable standards and no impact on safety and effectiveness is shown.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K963375](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K963375)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com