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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 K120325
Device Name CONNECTED CARE MOBILE APPLICATION
Applicant
WATERMARK MEDICAL
12715 falcon drive
brookfield,  WI  53005
Contact michael j leigh
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DQA   DXN   FRI   NBW  
Date Received02/02/2012
Decision Date 07/18/2012
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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