Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Device Classification Name device for sleep apnea testing based on mandibular movement
De Novo Number DEN210015
Device Name Sunrise Sleep Disorder Diagnostic Aid
Requester
sunrise
chaussée de marche 569/13
namur,  BE 5101
Contact francois naye
Regulation Number868.2376
Classification Product Code
QRS  
Date Received04/02/2021
Decision Date 01/07/2022
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Anesthesiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-