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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 Dr.
Brookfield,  WI  53005
Applicant Contact MICHAEL J LEIGH
Correspondent
Watermark Medical
12715 Falcon Dr.
Brookfield,  WI  53005
Correspondent 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 (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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