FDA.reportPublic FDA data

De Novo DEN140025

Device
BrainScope Ahead 100
Contact
michael e. singer
De Novo number
DEN140025
Product code
PIW
Regulation
882.1450
Classification name
brain injury adjunctive interpretive electroencephalograph assessment aid
Decision
granted (DENG)
Decision date
2014-11-17
Date received
2014-08-20
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
PIW
Device name
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Medical specialty
Neurology
Device class
2
Regulation
882.1450
Implant
N
Life sustain/support
N