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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 K250798
Device Name Control-IQ+ technology
Applicant
Tandem Diabetes Care, Inc.
12400 High Bluff Dr.
San Diego,  CA  92130
Applicant Contact Miriam Chan
Correspondent
Tandem Diabetes Care, Inc.
12400 High Bluff Dr.
San Diego,  CA  92130
Correspondent Contact Miriam Chan
Regulation Number862.1356
Classification Product Code
QJI  
Date Received03/14/2025
Decision Date 05/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT05403502
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
Recalls CDRH Recalls
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