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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K012241
Device Name CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
Applicant
Cardionet, Inc.
510 Market St.
San Diego,  CA  92101
Applicant Contact DONALD V CANAL
Correspondent
Cardionet, Inc.
510 Market St.
San Diego,  CA  92101
Correspondent Contact DONALD V CANAL
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/17/2001
Decision Date 02/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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