De Novo DEN170091

Device

EyeBOX

Contact

rosina samadani

De Novo number

DEN170091

Product code

QEA

Regulation

882.1455

Classification name

brain injury adjunctive interpretive oculomotor assessment aid

Decision

granted (DENG)

Decision date

2018-12-28

Date received

2017-12-22

Classification advisory

Neurology

Review advisory

Neurology

Type

Direct