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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name normalizing quantitative electroencephalograph software
510(k) Number K041263
Device Name NEUROGUIDE ANALYSIS SYSTEM
Original Applicant
APPLIED NEUROSCIENCE INC.
228 176th terrace drive
st. petersburg,  FL  33708
Original Contact robert w thatcher
Regulation Number882.1400
Classification Product Code
OLU  
Date Received05/11/2004
Decision Date 08/03/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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