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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 K113234
Model MHC2011.10
Device Name MOBCARDIO SYSTEM
Original Applicant
MOBHEALTH INCORPORATION
5227 village circle dr.
temple city,  CA  91780
Original Contact patricia lin
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/02/2011
Decision Date 11/17/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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