K251550
- 510(k) number
- K251550
- Device name
- NX01 (NX01)
- Applicant
- Naox Technologies Sas FR
- Product code
- OMC — Reduced- Montage Standard Electroencephalograph
- Decision date
- 2025-11-25
- Date received
- 2025-05-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K251550.pdf
Official FDA record: K251550
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.