510(k) DEN170045

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

February 14, 2018

Date Received

August 28, 2017

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Brain Trauma Assessment Test

Device Class

Class II

Regulation Number

866.5830

Review Panel

IM

Submission Type

Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care