Nox Sleep System

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Nox Medical

The following data is part of a premarket notification filed by Nox Medical with the FDA for Nox Sleep System.

Pre-market Notification Details

Device IDK192469
501k NumberK192469
Device Name:Nox Sleep System
ClassificationAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant Nox Medical Katrinartuni 2 Reykjavik,  IS 105
ContactKolburn E Ottosdottir
CorrespondentJohn J Smith
Hogan Lovells US LLP 555 Thirteenth Street, NW Washington,  DC  20004
Product CodeOLZ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-09
Decision Date2019-11-13

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