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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, insulin suspend
510(k) Number K193483
Device Name Basal-IQ Technology
Applicant
Tandem Diabetes Care, Inc.
11075 Roselle Street
san diego,  CA  92121
Applicant Contact trevor j dendo
Correspondent
Tandem Diabetes Care, Inc.
11075 Roselle Street
san diego,  CA  92121
Correspondent Contact trevor j denbo
Regulation Number862.1356
Classification Product Code
QJS  
Subsequent Product Code
NDC  
Date Received12/17/2019
Decision Date 02/28/2020
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
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