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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 K140360
Device Name HEALTH KIOSK
Applicant
Engagementhealth, LLC
601 W. 20 St.
Hialeah,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
Engagementhealth, LLC
601 W. 20 St.
Hialeah,  FL  33010
Correspondent Contact JORGE MILLAN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/12/2014
Decision Date 04/10/2015
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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