FDA.reportPublic FDA data

De Novo DEN180058

Device
t:slim X2 insulin pump with interoperable technology
Contact
michael sarrasin
De Novo number
DEN180058
Product code
QFG
Regulation
880.5730
Classification name
alternate controller enabled insulin infusion pump
Decision
granted (DENG)
Decision date
2019-02-14
Date received
2018-10-29
Classification advisory
Clinical Chemistry
Review advisory
Clinical Chemistry
Type
Direct

Current FDA Classification#

Product code
QFG
Device name
Alternate Controller Enabled Insulin Infusion Pump
Medical specialty
Clinical Chemistry
Device class
2
Regulation
880.5730
Implant
N
Life sustain/support
N