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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Attention Task Performance
510(k) Number K143468
Device Name QbCheck
Applicant
QBTECH AB
Kungsgatan 29
Stockholm,  SE 11156
Applicant Contact Hans Bostrom
Correspondent
QBTECH AB
Kungsgatan 29
Stockholm,  SE 11156
Correspondent Contact Hans Bostrom
Classification Product Code
LQD  
Date Received12/04/2014
Decision Date 03/22/2016
Decision Substantially Equivalent (SESE)
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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