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