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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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More FDA Info for this Product Code
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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