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Heartrac ECG Monitoring System

by Cardiac Telecom Corp.

510(k) K934913

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934913 Date5 Jun 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QYW
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Heartrac ECG Monitoring System is a Hospital Cardiac Telemetry device, designed for continuous electrocardiographic (ECG) monitoring of patients in clinical settings. It detects and alerts for arrhythmias, enabling real-time cardiac assessment and early intervention in cardiovascular care.

This system is supplied as a reusable medical device, intended for use in hospital environments where continuous cardiac monitoring is required. It operates under FDA clearance (510(k) K934913) and adheres to regulatory classification 2 under 21 CFR 870.1025. No specific sterility or MRI safety information is provided in the available data.

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