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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 K102496
Device Name POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
Applicant
CARDIAC SCIENCE CORPORATION
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021
Applicant Contact KATHLEEN ROBERTS
Correspondent
CARDIAC SCIENCE CORPORATION
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021
Correspondent Contact KATHLEEN ROBERTS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received08/31/2010
Decision Date 06/09/2011
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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