Sunrise Sleep Disorder Diagnostic Aid

Device For Sleep Apnea Testing Based On Mandibular Movement


The following data is part of a De Novo classification by Sunrise with the FDA for Sunrise Sleep Disorder Diagnostic Aid.

Pre-market Notification Details

DeNovo IDDEN210015
Device Name:Sunrise Sleep Disorder Diagnostic Aid
ClassificationDevice For Sleep Apnea Testing Based On Mandibular Movement
Applicant Sunrise chaussée De Marche 569/13 Namur,  BE 5101
ContactFrancois Naye
Product CodeQRS  
CFR Regulation Number868.2376 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardAnesthesiology
Classification AdvisoryEar Nose & Throat
Date Received2021-04-02
Decision Date2022-01-07
Reclassification Order:Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases


Device IdentifiersubmissionNumberSupplement
05430001896060 DEN210015 000
05430001896015 DEN210015 000

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