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 over-the-counter device to assess risk of sleep apnea
De Novo Number DEN230041
Device Name Sleep Apnea Feature
Requester
samsung electronics co., ltd.
129 samsung-ro, yeoungton-gu
suwon-si,  KR
Contact hon pak
Regulation Number868.2378
Classification Product Code
QZW  
Date Received05/31/2023
Decision Date 02/06/2024
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-