FDA 510(k) Applications for Medical Device Product Code "QJI"

FDA 510(k) Number Applicant Device Name Decision Date
K220916 Beta Bionics, Inc. iLet« Dosing Decision Software 05/19/2023
K232224 Beta Bionics, Inc. iLet« Dosing Decision Software 09/22/2023
K203774 Insulet Corporation SmartAdjust technology 01/27/2022
K220394 Insulet Corporation SmartAdjust(TM) technology 08/19/2022
DEN190034 Tandem Diabetes Care, Inc. Control-IQ Technology 12/13/2019
K200467 Tandem Diabetes Care, Inc. Control-IQ Technology 06/16/2020
K203689 Tidepool Project Tidepool Loop 01/23/2023


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact