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 alternate controller enabled insulin infusion pump
De Novo Number DEN180058
Device Name t:slim X2 insulin pump with interoperable technology
Requester
tandem diabetes care, inc.
11075 roselle st.
san diego,  CA  92121
Contact michael sarrasin
Regulation Number880.5730
Classification Product Code
QFG  
Date Received10/29/2018
Decision Date 02/14/2019
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
-
-