510(k) K052240

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 by Cardionet, Inc. — Product Code QYX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 19, 2005
Date Received: August 17, 2005
Clearance Type: Abbreviated
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)
K063222 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 (November 14, 2006)
K053263 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 (April 25, 2006)
K012241 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 (February 1, 2002)
K003707 — CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A (May 16, 2001)

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K160064 — MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (March 11, 2016)
K133753 — MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR (September 19, 2014)
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