FDA.reportPublic FDA data

De Novo DEN190034

Device
Control-IQ Technology
Contact
michael sarrasin
De Novo number
DEN190034
Product code
QJI
Regulation
862.1356
Classification name
interoperable automated glycemic controller
Decision
granted (DENG)
Decision date
2019-12-13
Date received
2019-07-15
Classification advisory
Clinical Chemistry
Review advisory
Clinical Chemistry
Type
Direct

Current FDA Classification#

Product code
QJI
Device name
Interoperable Automated Glycemic Controller
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.1356
Implant
N
Life sustain/support
N