K253237
- 510(k) number
- K253237
- Device name
- Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
- Applicant
- Elde Medikal Sanayi ve Ticaret Anonim Sirketi TR
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-05-08
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253237.pdf
Official FDA record: K253237
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.