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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 K093288
Device Name CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
Applicant
Cardionet, Inc.
1010 2nd Ave., Suite 700
San Diego,  CA  92101
Applicant Contact KENT SAYLER
Correspondent
Cardionet, Inc.
1010 2nd Ave., Suite 700
San Diego,  CA  92101
Correspondent Contact KENT SAYLER
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Code
DSI  
Date Received10/20/2009
Decision Date 04/08/2010
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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