K260453
- 510(k) number
- K260453
- Device name
- Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
- Applicant
- Bionit Labs Srl IT
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-03-12
- Date received
- 2026-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260453.pdf
Official FDA record: K260453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.