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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interoperable Automated Glycemic Controller
510(k) Number K232382
Device Name Control-IQ Technology
Applicant
Tandem Diabetes Care, Inc.
12400 High Bluff Dr.
San Diego,  CA  92130
Applicant Contact Christin Dunn
Correspondent
Tandem Diabetes Care, Inc.
12400 High Bluff Dr.
San Diego,  CA  92130
Correspondent Contact Christin Dunn
Regulation Number862.1356
Classification Product Code
QJI  
Date Received08/08/2023
Decision Date 11/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT04796779
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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