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Device brain injury adjunctive interpretive electroencephalograph assessment aid
Regulation Description Brain injury adjunctive interpretive electroencephalograph assessment aid.
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.
Product CodePIW
Regulation Number 882.1450
Device Class 2