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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K093211
Device Name CARECENTER MD
Applicant
Cardiac Science Corporation
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact THERESA MYERS
Correspondent
Cardiac Science Corporation
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact THERESA MYERS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/13/2009
Decision Date 06/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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