FDA.reportPublic FDA data

De Novo DEN160018

Device
reSet
Contact
nandini murthy
De Novo number
DEN160018
Product code
PWE
Regulation
882.5801
Classification name
computerized behavioral therapy device for substance use disorders
Decision
granted (DENG)
Decision date
2017-09-14
Date received
2016-05-16
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
PWE
Device name
Computerized Behavioral Therapy Device For Substance Use Disorders
Medical specialty
Neurology
Device class
2
Regulation
882.5801
Implant
N
Life sustain/support
N