PIW

9 FDA 510(k) clearances · Product code

FDA profile

Official device name

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Device class

Class II (moderate risk)

Regulation

21 CFR 882.1450

Medical specialty

Neurology

FDA 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.

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