FDA 510(k) Application Details - K020218

Device Classification Name Index-Generating Electroencephalograph Software

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510(K) Number K020218
Device Name Index-Generating Electroencephalograph Software
Applicant NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 882.1400

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Classification Product Code OLW
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Date Received 01/22/2002
Decision Date 04/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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