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FDA 510(k) Application Details - K023536
Device Classification Name
Non-Normalizing Quantitative Electroencephalograph Software
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510(K) Number
K023536
Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Applicant
NEUROSCAN
7850 PASEO DEL NORTE
SUITE 101
EL PASO, TX 79912 US
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Contact
ELVIRA GARCIA
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Regulation Number
882.1400
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Classification Product Code
OLT
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More FDA Info for this Product Code
Date Received
10/21/2002
Decision Date
01/15/2003
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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