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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 K052161
Device Name POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
Applicant
CARDIAC SCIENCE, INC.
1900 MAIN ST., SUITE 700
IRVINE,  CA  92614
Applicant Contact KENNETH F OLSON
Correspondent
CARDIAC SCIENCE, INC.
1900 MAIN ST., SUITE 700
IRVINE,  CA  92614
Correspondent Contact KENNETH F OLSON
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received08/09/2005
Decision Date 10/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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