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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 K203234
Device Name t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
Applicant
Tandem Diabetes Care, Inc.
11075 Roselle St.
San Diego,  CA  92121
Applicant Contact Ashley Reynolds
Correspondent
Tandem Diabetes Care, Inc.
11075 Roselle St.
San Diego,  CA  92121
Correspondent Contact Ashley Reynolds
Regulation Number880.5730
Classification Product Code
QFG  
Date Received11/03/2020
Decision Date 02/15/2022
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
Recalls CDRH Recalls
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