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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 K060934
Device Name MODIFICATION TO POWERHEART ECD
Applicant
CARDIAC SCIENCE CORPORATION
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021
Applicant Contact CHERYL SHEA
Correspondent
CARDIAC SCIENCE CORPORATION
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021
Correspondent Contact CHERYL SHEA
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received04/05/2006
Decision Date 05/15/2006
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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