FDA 510(k), K193483, Basal-IQ Technology

510(K) Number: K193483
Device Name: Basal-IQ Technology
Manufacturer: Tandem Diabetes Care, Inc.
Device Classification Name: Interoperable Automated Glycemic Controller, Insulin Suspend
Regulation Number: 862.1356
Classification Product Code: QJS
Date Received: 12/17/2019
Decision Date: 02/28/2020
Regulation Medical Specialty: Clinical Chemistry

1,554 pages (2,749 of 4,303 original pages are fully redacted)