FDA 510(k) Application Details - K020800

Device Classification Name Recorder, Attention Task Performance

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510(K) Number K020800
Device Name Recorder, Attention Task Performance
Applicant OPTAX SYSTEMS, INC.
7 TIFFANY TRAIL
HOPKINTON, MA 01748 US
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Contact DEBBIE IAMPIETRO
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Regulation Number 000.0000

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Classification Product Code LQD
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Date Received 03/12/2002
Decision Date 06/10/2002
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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