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510(k) K222239

SmartBolus Calculator by Insulet Corporation — Product Code QRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2022
Date Received
July 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Continuous Glucose Monitor Informed Insulin Dose Calculator
Device Class
Class II
Regulation Number
862.1358
Review Panel
CH
Submission Type

A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.

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