K242326
- 510(k) number
- K242326
- Device name
- Wave Electrode (AE02-60); Wave Electrode (AE02-50)
- Applicant
- Bionit Labs Srl IT
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2025-01-02
- Date received
- 2024-08-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242326.pdf
Official FDA record: K242326
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.