FDA 510(k), K200467, Control-IQ Technology

510(K) Number: K200467
Device Name: Control-IQ Technology
Manufacturer: Tandem Diabetes Care, Inc.
Device Classification Name: interoperable automated glycemic controller
Regulation Number: 862.1356
Classification Product Code: QJI
Date Received: 02/26/2020
Decision Date: 06/16/2020
Regulation Medical Specialty: Clinical Chemistry

1,739 pages (3,695 of 5,434 original pages are fully redacted)