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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K071446
Device Name ELECTRODE ARRAY CAP
Applicant
Electrode Arrays
612 N. Resler
El Paso,  TX  79912
Applicant Contact ELVIRA GARCIA
Correspondent
Electrode Arrays
612 N. Resler
El Paso,  TX  79912
Correspondent Contact ELVIRA GARCIA
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/24/2007
Decision Date 07/02/2008
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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