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 Interoperable Automated Glycemic Controller
510(k) Number K251152
Device Name DBLG2
Applicant
Diabeloop
17 Rue Felix Esclangon
Grenoble,  FR 38000
Applicant Contact Erik Huneker
Correspondent
Diabeloop
17 Rue Felix Esclangon
Grenoble,  FR 38000
Correspondent Contact Erik Huneker
Regulation Number862.1356
Classification Product Code
QJI  
Date Received04/14/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02987556
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
-
-