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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 K254183
Device Name MR Conditional Cup Electrodes
Applicant
Technomed Europe
Wiebachstraat 25a
Limburg,  NL 6466
Applicant Contact Zara Grimshaw
Correspondent
Technomed Europe
Wiebachstraat 25a
Limburg,  NL 6466
Correspondent Contact Zara Grimshaw
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/23/2025
Decision Date 05/07/2026
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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