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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K022929
Device Name PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210
Applicant
Cardiac Science, Inc.
16931 Millikan Ave.
Irvine,  CA  92606
Applicant Contact JOHN CARLINE
Correspondent
Cardiac Science, Inc.
16931 Millikan Ave.
Irvine,  CA  92606
Correspondent Contact JOHN CARLINE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/04/2002
Decision Date 01/27/2003
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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