FDA 510(k) Application Details - K000812

Device Classification Name Electromyograph, Diagnostic

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510(K) Number K000812
Device Name Electromyograph, Diagnostic
Applicant NEUROSOFT, INC.
5700 CROMO DR.
SUITE 100
EL PASO, TX 79912 US
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Contact DAVID B JONES
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Regulation Number 890.1375

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Classification Product Code IKN
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Date Received 03/13/2000
Decision Date 05/17/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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