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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 K040894
Device Name QBTEST
Applicant
QBTECH AB
MIMERGATAN 5
GOTEBORG,  SE 417 64
Applicant Contact MARIA BERGLUND
Correspondent
QBTECH AB
MIMERGATAN 5
GOTEBORG,  SE 417 64
Correspondent Contact MARIA BERGLUND
Classification Product Code
LQD  
Date Received04/06/2004
Decision Date 06/22/2004
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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