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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 Number
862.1356
Classification Product Code
QJI
Date Received
02/26/2020
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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