FDA 510(k) Application Details - K122149

Device Classification Name Recorder, Attention Task Performance

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510(K) Number K122149
Device Name Recorder, Attention Task Performance
Applicant QBTECH AB
Kungsgatan 29
Stockholm 11156 SE
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Contact HANS BOSTROM
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Regulation Number 000.0000

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Classification Product Code LQD
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Date Received 07/19/2012
Decision Date 10/17/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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