Noxturnal Web

FDA 510(k) K260585 · Nox Medical Ehf

Substantially Equivalent

510(k) numberK260585

Submission

Device name
Noxturnal Web
Applicant
Nox Medical Ehf
Reykjavik, IS
Received
February 20, 2026
Decision date
March 20, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OLV – Standard Polysomnograph With Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Specialty
Neurology

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

Other 510(k)s with product code OLV

510(k)DeviceApplicantDecision
K261747Report StudioOLV · Traditional Beacon Biosignals, Inc.08/25/2026SE
K242447Falcon HSTOLV · Traditional Compumedics Limited02/20/2025SE
K241288Noxturnal WebOLV · Traditional Nox Medical Ehf12/23/2024SE
K240700HomeSleepTest (HST, HST REM+)OLV · Traditional Somnomedics GmbH12/08/2024SE
K213007Cerebra Sleep SystemOLV · Traditional Cerebra Medical , Ltd.07/06/2022SE
K201054SOMNOscreen plusOLV · Traditional Somnomedics GmbH08/12/2020SE
K192624ApneaTrakOLV · Traditional Cadwell Industries, Inc.02/20/2020SE
K181709Serenity Piezo Sensor, Serenity Thermocouple SensorOLV · Traditional Neurotronics, Inc.11/16/2018SE
K173868Serenity Body Position Sensor, Serenity RIP SensorsOLV · Traditional Neurotronics, Inc.07/02/2018SE
K173690Grass TWinOLV · Special Natus Medical Incorporated Dba Excel-Tech Ltd.…03/09/2018SE

More from Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

510(k)DeviceDecision
K252330DeepRESPOLZ · Traditional 11/17/2025SE
K241960DeepRESPOLZ · Traditional 03/14/2025SE
K241288Noxturnal WebOLV · Traditional 12/23/2024SE
K151361Nox RIP Belts & CablesMNR · Traditional 11/06/2015SE

Questions and answers

When was Noxturnal Web cleared by the FDA?

Noxturnal Web (K260585) received a 510(k) decision of Substantially Equivalent on March 20, 2026, 28 days after the submission was received.

What is the product code of K260585?

The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.