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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alternate Controller Enabled Insulin Infusion Pump
510(k) Number K250792
Device Name t:slim X2 insulin pump with interoperable 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 Number880.5730
Classification Product Code
QFG  
Date Received03/14/2025
Decision Date 09/24/2025
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
Predetermined Change
Control Plan Authorized		 No
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