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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 K241045
Device Name Disposable Subdermal Needle Electrode, Corkscrew
Applicant
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Applicant Contact Sanne Habets
Correspondent
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Correspondent Contact Sanne Habets
Regulation Number882.1350
Classification Product Code
GXZ  
Subsequent Product Code
IKT  
Date Received04/17/2024
Decision Date 12/11/2024
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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