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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 K122149
Model 3.5
Device Name QBTES
Original Applicant
kungsgatan 29
stockholm,  SE 11156
Original Contact hans bostrom
Classification Product Code
Date Received07/19/2012
Decision Date 10/17/2012
Decision substantially equivalent (SE)
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No