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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name continuous glucose monitor informed insulin dose calculator
510(k) Number K231824
Device Name SmartBolus Calculator
Applicant
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Maria Brower
Correspondent
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Maria Brower
Regulation Number862.1358
Classification Product Code
QRX  
Subsequent Product Code
NDC  
Date Received06/21/2023
Decision Date 10/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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