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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 K031987
Device Name POWERHEART AED G3, MODEL 9300
Applicant
CARDIAC SCIENCE
5474 FELTL RD.
MINNEAPOLIS,  MN  55343
Applicant Contact KENNETH OLSON
Correspondent
CARDIAC SCIENCE
5474 FELTL RD.
MINNEAPOLIS,  MN  55343
Correspondent Contact KENNETH OLSON
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received06/27/2003
Decision Date 07/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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