K254183
- 510(k) number
- K254183
- Device name
- MR Conditional Cup Electrodes
- Applicant
- Technomed Europe NL
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-05-07
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K254183.pdf
Official FDA record: K254183
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.