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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 K200467
Device Name Control-IQ Technology
Applicant
Tandem Diabetes Care, Inc.
11075 Roselle Street
san diego,  CA  92121
Applicant Contact michael sarrasin
Correspondent
Tandem Diabetes Care, Inc.
11075 Roselle Street
san diego,  CA  92121
Correspondent Contact michael sarrasin
Regulation Number862.1356
Classification Product Code
QJI  
Date Received02/26/2020
Decision Date 06/16/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02679287
NCT02844517
NCT02985866
NCT03368937
NCT03369067
NCT03591354
NCT03674281
NCT03804983
NCT03844789
Reviewed by Third Party No
Combination Product No
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