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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K143332
Device Name Fast Sphyg by Koven
Applicant
Koven Technology, Inc.
12125 Woodcrest Executive Dr.
Suite 320
St Louis,  MO  63141
Applicant Contact HEATHER BELL
Correspondent
Koven Technology, Inc.
12125 Woodcrest Executive Dr.
Suite 320
St Louis,  MO  63141
Correspondent Contact HEATHER BELL
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received11/20/2014
Decision Date 04/14/2015
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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