The following data is part of a De Novo classification by Sunrise with the FDA for Sunrise Sleep Disorder Diagnostic Aid.
DeNovo ID | DEN210015 |
Device Name: | Sunrise Sleep Disorder Diagnostic Aid |
Classification | Device For Sleep Apnea Testing Based On Mandibular Movement |
Applicant | Sunrise chaussée De Marche 569/13 Namur, BE 5101 |
Contact | Francois Naye |
Product Code | QRS |
CFR Regulation Number | 868.2376 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device 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 Board | Anesthesiology |
Classification Advisory | Ear Nose & Throat |
Type | Direct |
Date Received | 2021-04-02 |
Decision Date | 2022-01-07 |
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 Identifier | submissionNumber | Supplement |
---|---|---|
05430001896060 | DEN210015 | 000 |
05430001896015 | DEN210015 | 000 |