K260585
- 510(k) number
- K260585
- Device name
- Noxturnal Web
- Applicant
- Nox Medical Ehf IS
- Product code
- OLV — Standard Polysomnograph With Electroencephalograph
- Decision date
- 2026-03-20
- Date received
- 2026-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260585.pdf
Official FDA record: K260585
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.