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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K120320
Device Name CONNECTED CARE CLINICAL APPLICATION
Applicant
WATERMARK MEDICAL INC
1117 Perimeter Ctr W Suite W514
Atlanta,  GA  30338
Applicant Contact MICHAEL J LEIGH
Correspondent
WATERMARK MEDICAL INC
1117 Perimeter Ctr W Suite W514
Atlanta,  GA  30338
Correspondent Contact MICHAEL J LEIGH
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   FRI   NBW  
Date Received02/02/2012
Decision Date 08/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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