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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 K092061
Device Name FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217
Applicant
Genexel Medical Instrument, Inc.
845 Aronson Lake Ct.
Roswell,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
Genexel Medical Instrument, Inc.
845 Aronson Lake Ct.
Roswell,  GA  30075
Correspondent Contact JAY MANSOUR
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/08/2009
Decision Date 03/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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