Devices · BrainScope Company, Inc.

BrainScope TBI

BrainScope Company, Inc. is listed for BrainScope TBI (K190815). The FDA list gives September 11, 2019 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PIW as “Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid”: A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190815

Official FDA database record

Date of final decision

September 11, 2019

Company on the FDA list

BrainScope Company, Inc.

Lead panel

Neurology

Primary product code

PIW

openFDA device name for the code

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Device class

2

Regulation number

882.1450

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary