Noxturnal Web— 510(k) K260585

Substantially Equivalent

Nox Medical Ehf

FDA 510(k) clearance K260585 for Noxturnal Web, Substantially Equivalent on 2026-03-20. Applicant: Nox Medical Ehf. Device class: 2.

Clearance details

Applicant: Nox Medical Ehf
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2026-02-20
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Reykjavik, IS

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLV

K261747 — Report Studio2026-08-25
K242447 — Falcon HST2025-02-20
K241288 — Noxturnal Web2024-12-23
K240700 — HomeSleepTest (HST, HST REM+)2024-12-08
K213007 — Cerebra Sleep System2022-07-06

More clearances from Nox Medical Ehf

K252330 — DeepRESP2025-11-17
K241960 — DeepRESP2025-03-14
K151361 — Nox RIP Belts & Cables2015-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.