510(k) K063222

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 by Cardionet, Inc. — Product Code QYX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 14, 2006
Date Received: October 24, 2006
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Outpatient Cardiac Telemetry
Device Class: Class II
Regulation Number: 870.1025
Review Panel: CV
Submission Type

Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.

Other clearances by Cardionet, Inc.

K093288 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION (April 8, 2010)
K072558 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 (December 5, 2007)
K053263 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 (April 25, 2006)
K052240 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 (October 19, 2005)
K012241 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 (February 1, 2002)
K003707 — CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A (May 16, 2001)

Other clearances for product code QYX

K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (July 11, 2025)
K240653 — SmartCardia 7L Platform (MCT) (October 31, 2024)
K240029 — Zio AT® device (A100A1001) (October 21, 2024)
K233584 — RhythmStar System (July 8, 2024)
K162956 — NOWCARDIO SYSTEM (September 22, 2017)
K170565 — LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (August 1, 2017)
K163512 — Zio AT ECG Monitoring System (June 2, 2017)
K160064 — MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (March 11, 2016)
K133753 — MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR (September 19, 2014)
K133701 — NUVANT MCT SYSTEM (February 6, 2014)