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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Spectrum, Electroencephalogram Signal
510(k) Number K925735
Device Name EEG ANALYZER
Applicant
Bio-Scan, Inc.
3200 Pleasant Run Rd.
Suite 105
Lancaster,  TX  75146
Applicant Contact RONALD K WEBER
Correspondent
Bio-Scan, Inc.
3200 Pleasant Run Rd.
Suite 105
Lancaster,  TX  75146
Correspondent Contact RONALD K WEBER
Regulation Number882.1420
Classification Product Code
GWS  
Date Received11/13/1992
Decision Date 12/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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