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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 K040438
Device Name POWERHEART AED G3A
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 Received02/19/2004
Decision Date 07/01/2004
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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