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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 K143108
Device Name HealthGuard-15
Applicant
Futrex, Inc.
130 Western Maryland Pkwy.
Hagerstown,  MD  21740
Applicant Contact Carole Rosenthal
Correspondent
Futrex, Inc.
130 Western Maryland Pkwy.
Hagerstown,  MD  21740
Correspondent Contact Carole Rosenthal
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
MNW  
Date Received10/29/2014
Decision Date 03/27/2015
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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