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

510(k) Premarket Notification
  • 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
510(k) Number K233044
Device Name Tandem Mobi insulin pump with interoperable technology
Applicant
Tandem Diabetes Care, Inc.
12400 High Bluff Dr.
San Diego,  CA  92130
Applicant Contact Louise Focht
Correspondent
Tandem Diabetes Care, Inc.
12400 High Bluff Dr.
San Diego,  CA  92130
Correspondent Contact Louise Focht
Regulation Number880.5730
Classification Product Code
QFG  
Date Received09/25/2023
Decision Date 10/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-