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 insulin pump therapy adjustment calculator for healthcare professionals
De Novo Number DEN170043
Device Name DreaMed Advisor Pro
Requester
dreamed diabetes, ltd.
3 shimshon st.
petah tikva, pob 3271,  IL 4952701
Contact eran atlas
Regulation Number862.1358
Classification Product Code
QCC  
Date Received08/17/2017
Decision Date 06/12/2018
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-