De Novo DEN110019

Device
NEBA SYSTEM
Contact
e. howard merry
De Novo number
DEN110019
Product code
NCG
Regulation
882.1440
Classification name
neuropsychiatric interpretative electroencephalograph assessment aid
Decision
granted (DENG)
Decision date
2013-07-15
Date received
2011-12-08
Classification advisory
Neurology
Review advisory
Neurology
Type
Post-NSE

Current FDA Classification#

Product code
NCG
Device name
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Medical specialty
Neurology
Device class
2
Regulation
882.1440
Implant
N
Life sustain/support
N