FDA 510(k), K201214, t:slim X2 Insulin Pump with Interoperable Technology

510(K) Number: K201214
Device Name: t:slim X2 Insulin Pump with Interoperable Technology
Manufacturer: Tandem Diabetes Care, Inc.
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: 880.5730
Classification Product Code: QFG
Date Received: 05/05/2020
Decision Date: 06/04/2020
Regulation Medical Specialty: Clinical Chemistry

522 pages (263 of 785 original pages are fully redacted)