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 infant pulse rate and oxygen saturation monitor for over-the-counter use
De Novo Number DEN220091
Device Name Dream Sock
Requester
owlet baby care, inc.
3300 n. ashton blvd. suite 300
lehi,  UT  84043
Contact jim fidacaro
Regulation Number870.2705
Classification Product Code
QYU  
Date Received12/14/2022
Decision Date 11/08/2023
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-