Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
PIW · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1450
Classification
FDA Product Code
PIW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.1450
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.