FDA.reportPublic FDA data

De Novo DEN170045

Device
Banyan BTI
Contact
steven p. richieri
De Novo number
DEN170045
Product code
QAT
Regulation
866.5830
Classification name
brain trauma assessment test
Decision
granted (DENG)
Decision date
2018-02-14
Date received
2017-08-28
Classification advisory
Immunology
Review advisory
Immunology
Type
Direct

Current FDA Classification#

Product code
QAT
Device name
Brain Trauma Assessment Test
Medical specialty
Immunology
Device class
2
Regulation
866.5830
Implant
N
Life sustain/support
N