FDA 510(k) Application Details - K001324

Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software

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510(K) Number K001324
Device Name Non-Normalizing Quantitative Electroencephalograph Software
Applicant NEURO SCAN LABS
5700 CROMO DR., SUITE 100
EL PASO, TX 79912-5538 US
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Contact DAVID B JONES
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Regulation Number 882.1400

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Classification Product Code OLT
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Date Received 04/26/2000
Decision Date 07/11/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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