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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K023536
Device Name NUAMPS
Applicant
Neuroscan
7850 Paseo Del Norte
Suite 101
El Paso,  TX  79912
Applicant Contact ELVIRA GARCIA
Correspondent
Neuroscan
7850 Paseo Del Norte
Suite 101
El Paso,  TX  79912
Correspondent Contact ELVIRA GARCIA
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
GWQ  
Date Received10/21/2002
Decision Date 01/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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