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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K961817
Device Name B SMART MODEL 1
Applicant
KOVEN TECHNOLOGY, INC.
300 BROOKES DR.
SUITE 105
ST. LOUIS,  MO  63042
Applicant Contact PAUL G KOVEN
Correspondent
KOVEN TECHNOLOGY, INC.
300 BROOKES DR.
SUITE 105
ST. LOUIS,  MO  63042
Correspondent Contact PAUL G KOVEN
Regulation Number882.5050
Classification Product Code
LEL  
Date Received05/10/1996
Decision Date 07/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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