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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K011241
Device Name NEUROSOFT'S SOURCE
Applicant
Neurosoft, Inc.
5700 Cromo, Suite 100
El Paso,  TX  79912
Applicant Contact ELVIRA GARCIA
Correspondent
Neurosoft, Inc.
5700 Cromo, Suite 100
El Paso,  TX  79912
Correspondent Contact ELVIRA GARCIA
Regulation Number882.1400
Classification Product Code
OLX  
Date Received04/23/2001
Decision Date 09/19/2001
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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