Cleared Traditional

Noxturnal Web

K241288 · Nox Medical Ehf · Neurology
Dec 2024
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K241288 is an FDA 510(k) clearance for the Noxturnal Web, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Nox Medical Ehf (Reykjavik, IS). The FDA issued a Cleared decision on December 23, 2024, 230 days after receiving the submission on May 7, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K241288 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2024
Decision Date December 23, 2024
Days to Decision 230 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLV — Standard Polysomnograph With Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition 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.