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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K122285
Device Name TABLET COMMANDER
Original Applicant
CARDIOCOM LLC
7980 century blvd.
chanhassen,  MN  55317
Original Contact daniel l cosentino
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/30/2012
Decision Date 08/14/2012
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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