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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 K222888
Device Name BlueStar CGM insulin dose calculator
Applicant
Welldoc, Inc.
10221 Wincopin Circle
Suite #150
Columbia,  MD  21044
Applicant Contact Ian Cadieux
Correspondent
Welldoc, Inc.
10221 Wincopin Circle
Suite #150
Columbia,  MD  21044
Correspondent Contact Ian Cadieux
Regulation Number862.1358
Classification Product Code
QRX  
Date Received09/23/2022
Decision Date 08/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT05229445
NCT05343065
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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