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
K232603 CamDiab Ltd. CamAPS FX 05/23/2024
K234055 Deka Research and Development DEKA Loop 03/13/2024
K203774 Insulet Corporation SmartAdjust technology 01/27/2022
K220394 Insulet Corporation SmartAdjust(TM) technology 08/19/2022
K232741 Insulet Corporation SmartAdjust(TM) technology 05/29/2024
K241777 Insulet Corporation SmartAdjustÖ Technology 08/26/2024
DEN190034 Tandem Diabetes Care, Inc. Control-IQ Technology 12/13/2019
K200467 Tandem Diabetes Care, Inc. Control-IQ Technology 06/16/2020
K232382 Tandem Diabetes Care, Inc. Control-IQ Technology 11/03/2023
K243823 Tandem Diabetes Care, Inc. Control-IQ+ technology 02/24/2025
K250798 Tandem Diabetes Care, Inc. Control-IQ+ technology 05/21/2025
K203689 Tidepool Project Tidepool Loop 01/23/2023


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