MR Conditional Cup Electrodes
FDA 510(k) K254183 · Technomed Europe
510(k) numberK254183
Submission
- Device name
- MR Conditional Cup Electrodes
- Applicant
- Technomed Europe
Limburg, NL - Received
- December 23, 2025
- Decision date
- May 7, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MR Conditional Cup Electrodes cleared by the FDA?
MR Conditional Cup Electrodes (K254183) received a 510(k) decision of Substantially Equivalent on May 7, 2026, 135 days after the submission was received.
What is the product code of K254183?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.