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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 K040637
Device Name POWERHEART AED G3 PRO
Applicant
CARDIAC SCIENCE, INC.
5474 FELTL RD.
MINNETONKA,  MN  55343
Applicant Contact KENNETH OLSON
Correspondent
CARDIAC SCIENCE, INC.
5474 FELTL RD.
MINNETONKA,  MN  55343
Correspondent Contact KENNETH OLSON
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received03/10/2004
Decision Date 08/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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