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FDA 510(k) Application Details - K011241
Device Classification Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
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510(K) Number
K011241
Device Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant
NEUROSOFT, INC.
5700 CROMO, SUITE 100
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
OLX
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More FDA Info for this Product Code
Date Received
04/23/2001
Decision Date
09/19/2001
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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