FDA 510(k), K183206, Dexcom G6 Continuous Glucose Monitoring System

510(K) Number: K183206
Device Name: Dexcom G6 Continuous Glucose Monitoring System
Manufacturer: Bryan Osborne
Device Classification Name: Integrated Continuous Glucose Monitoring System, Factory Calibrated
Regulation Number: QBJ
Classification Product Code: 11/19/2018
Date Received: 02/14/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry

678 pages (4,189 of 4,867 original pages are fully redacted)