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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 K052316
Device Name POWERHEART ECD
Applicant
CARDIAC SCIENCE, INC.
5474 FELTL ROAD
EDINA,  MN  55343
Applicant Contact KENNETH OLSON
Correspondent
CARDIAC SCIENCE, INC.
5474 FELTL ROAD
EDINA,  MN  55343
Correspondent Contact KENNETH OLSON
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received08/25/2005
Decision Date 01/03/2006
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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