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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 K243823
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 Geena George
Regulation Number862.1356
Classification Product Code
QJI  
Date Received12/12/2024
Decision Date 02/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT05785832
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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