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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Outpatient Cardiac Telemetry
510(k) Number K072558
Device Name CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
Applicant
Cardionet, Inc.
1010 2nd Ave., Suite 700
San Diego,  CA  92101
Applicant Contact JACK GAIKWAD
Correspondent
Cardionet, Inc.
1010 2nd Ave., Suite 700
San Diego,  CA  92101
Correspondent Contact JACK GAIKWAD
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Codes
DSI   MLO  
Date Received09/11/2007
Decision Date 12/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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