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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
FOIA Releasable 510(k) K041263
Device Name NEUROGUIDE ANALYSIS SYSTEM
Applicant
Applied Neuroscience, Inc.
228 176th Terrace Dr.
St. Petersburg,  FL  33708
Applicant Contact ROBERT W THATCHER
Correspondent
Applied Neuroscience, Inc.
228 176th Terrace Dr.
St. Petersburg,  FL  33708
Correspondent Contact ROBERT W THATCHER
Regulation Number882.1400
Classification Product Code
OLU  
Date Received05/11/2004
Decision Date 08/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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