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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 K122758
Device Name POWERHEART G5 AED
Original Applicant
CARDIAC SCIENCE CORPORATION
n7 w22025 johnson dr
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waukesha,  WI  53186
Original Contact kathleen roberts
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/10/2012
Decision Date 02/12/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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