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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K192603
Device Name Spes Medica Subdermal Needle Electrodes
Applicant
Spes Medica Srl
Via Europa - Zona Industriale
Battipaglia (Sa),  IT 84091
Applicant Contact Giorgio Facco
Correspondent
Spes Medica Srl
Via Europa - Zona Industriale
Battipaglia (Sa),  IT 84091
Correspondent Contact Giorgio Facco
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received09/20/2019
Decision Date 11/22/2019
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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