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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 K130136
Device Name DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
Applicant
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Applicant Contact PIERRE VREULS
Correspondent
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Correspondent Contact PIERRE VREULS
Regulation Number882.1350
Classification Product Code
GXZ  
Subsequent Product Code
IKT  
Date Received01/18/2013
Decision Date 07/19/2013
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
Recalls CDRH Recalls
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