FDA.reportPublic FDA data

De Novo DEN170088

Device
Dexcom G6 Continuous Glucose Monitoring System
Contact
neeta sharma
De Novo number
DEN170088
Product code
QBJ
Regulation
862.1355
Classification name
integrated continuous glucose monitoring system, factory calibrated
Decision
granted (DENG)
Decision date
2018-03-27
Date received
2017-12-08
Classification advisory
Clinical Chemistry
Review advisory
Clinical Chemistry
Type
Direct

Current FDA Classification#

Product code
QBJ
Device name
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.1355
Implant
N
Life sustain/support
N