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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
Model RESTING ECG, MODULES USB OR BT, STRESS-RESTING ECG, MODULES USB OR BT
Device Name CARECENTER MD
Original Applicant
CARDIAC SCIENCE CORPORATION
3303 monte villa pkwy.
bothell,  WA  98021
Original Contact theresa myers
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/13/2009
Decision Date 06/03/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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