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Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA product code PIW · 7 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1450
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-09-22 – 2025-03-27

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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