Noxturnal Web— 510(k) K260585
Substantially EquivalentNox Medical Ehf
FDA 510(k) clearance K260585 for Noxturnal Web, Substantially Equivalent on 2026-03-20. Applicant: Nox Medical Ehf. Device class: 2.
Summary
Nox Medical's Noxturnal Web is filed under OLV, standard polysomnographs with electroencephalograph. The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 882.1400. It was a Special 510(k), and Neurology is both the classification panel and the review panel.
Nox Medical filed from Reykjavik, Iceland. The decision came 28 calendar days after FDA received it (February 20 to March 20, 2026).
Clearance details
- Applicant
- Nox Medical Ehf
- Product code
- Product code OLV
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Reykjavik, IS
Recent devices under product code OLV
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