MR Conditional Cup Electrodes— 510(k) K254183
Substantially EquivalentTechnomed Europe
FDA 510(k) clearance K254183 for MR Conditional Cup Electrodes, Substantially Equivalent on 2026-05-07. Applicant: Technomed Europe. Device class: 2.
Summary
Technomed Europe's MR Conditional Cup Electrodes are filed under GXY, cutaneous electrodes.
Class II, 21 CFR 882.1320. Neurology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Technomed filed from Limburg, Netherlands. The decision came 135 calendar days after receipt (December 23, 2025 to May 7, 2026).
Clearance details
- Applicant
- Technomed Europe
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Limburg, NL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.