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FDA 510(k) Applications for Medical Device Product Code "QRX"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K203772
Insulet Corporation
Omnipod 5 SmartBolus Calculator
01/27/2022
K222239
Insulet Corporation
SmartBolus Calculator
08/19/2022
K222888
Welldoc, Inc.
BlueStar CGM insulin dose calculator
08/11/2023
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