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NOX T3 Noxturnal (PC Application)

by Nox Medical EUDAMED510(k)GUDID

Active European Union and United States

510(k) K082113Ref 539010Model NOX-NOXT_CD

Overview

The NOX T3 Noxturnal is a Ventilatory Effort Recorder, designed to monitor and assess ventilatory effort during sleep. It measures nasal airflow and thoracic-abdominal movements to evaluate respiratory patterns, aiding in the diagnosis and management of conditions such as obstructive sleep apnea and other sleep-related breathing disorders.

This device is a software application for personal computers, intended for use in clinical settings by healthcare professionals. It operates as a single-use digital tool, requiring no sterilization, and is compatible with standard PC environments. The NOX T3 Noxturnal has received FDA 510K clearance and complies with the Medical Device Directive (MDD), with regulatory classification as a Class II device under the EU system. No MRI safety information or physical size specifications are provided.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-15694311110255 Basic UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15694311110255 UDI-DIDate16 Sep 2016ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK082113 Date7 Nov 2008ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States FDA 510(k) Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-0031-2022 FDA Class II initiated 7 Sep 2021

    Error in the device firmware results in the inaccurate detection of device position.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Noxturnal®
Generic Name
Sleep disorder interpretive software, professional-only
Model / Ref / Catalog
NOX-NOXT_CD, 539010
Primary DI / UDI-DI
15694311110255
Basic UDI-DI
B-15694311110255
510(k) Number
FDA Product Code
MNR
EMDN Code
Z12100582 Polysomnography instruments - software accessories
GMDN Term
Sleep disorder interpretive software, professional-only
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 868.2375
Market of Registration
Iceland
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

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Questions

  • What clinical conditions is the NOX T3 Noxturnal software application designed to help diagnose or manage?

    The NOX T3 Noxturnal is specifically designed to monitor and assess ventilatory effort during sleep, helping evaluate respiratory patterns. It aids in diagnosing and managing conditions such as obstructive sleep apnea and other sleep-related breathing disorders by measuring nasal airflow and thoracic-abdominal movements.

  • Is the NOX T3 Noxturnal software a reusable tool or intended for single-use?

    The NOX T3 Noxturnal is a single-use digital tool, meaning it is intended for one-time use in a clinical setting. Since it is a software application, there is no need for sterilization or physical reuse.

  • What type of computer compatibility does the NOX T3 Noxturnal require for use?

    The NOX T3 Noxturnal is designed for use with standard personal computers, making it compatible with typical clinical PC environments. No specific hardware specifications beyond this are provided.

  • How is the regulatory status of the NOX T3 Noxturnal defined in the U.S. and Europe?

    In the U.S., the NOX T3 Noxturnal has received FDA 510(k) clearance, indicating it is deemed substantially equivalent to a predicate device. In Europe, it complies with the Medical Device Directive (MDD) and is classified as a Class II device under EU regulations.

  • What is the primary purpose of the NOX T3 Noxturnal software in a clinical workflow?

    The NOX T3 Noxturnal serves as a Ventilatory Effort Recorder, providing healthcare professionals with data to analyze respiratory effort during sleep. This helps in diagnosing and managing sleep-related breathing disorders, such as obstructive sleep apnea, by offering detailed insights into airflow and movement patterns.

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No