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FDA 510(k) Application Details - K041263
Device Classification Name
Normalizing Quantitative Electroencephalograph Software
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510(K) Number
K041263
Device Name
Normalizing Quantitative Electroencephalograph Software
Applicant
APPLIED NEUROSCIENCE INC.
228 176TH TERRACE DRIVE
ST. PETERSBURG, FL 33708 US
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Contact
ROBERT W THATCHER
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Regulation Number
882.1400
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Classification Product Code
OLU
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More FDA Info for this Product Code
Date Received
05/11/2004
Decision Date
08/03/2004
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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