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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 K120494
Device Name DISPOSABLE ADHESIVE SURFACE ELECTRODE
Applicant
Spes Medica Srl
Via Europa-Zona Industriale
Battipaglia,  IT 84091
Applicant Contact ALFREDO SPADAVECHIA
Correspondent
Spes Medica Srl
Via Europa-Zona Industriale
Battipaglia,  IT 84091
Correspondent Contact ALFREDO SPADAVECHIA
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/17/2012
Decision Date 06/11/2012
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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