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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
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