MR Conditional Cup Electrodes— 510(k) K254183

Substantially Equivalent

Technomed Europe

FDA 510(k) clearance K254183 for MR Conditional Cup Electrodes, Substantially Equivalent on 2026-05-07. Applicant: Technomed Europe.

Clearance details

Applicant: Technomed Europe
Product code: Code GXY
Advisory panel: Neurology
Date received: 2025-12-23
Decision date: 2026-05-07
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.