FDA 510(k), K183206, Dexcom G6 Continuous Glucose Monitoring System
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: KXA
Date Received: 11/19/2018
Decision Date: 02/14/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
678 pages (4,189 of 4,867 original pages are fully redacted)
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