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Neuropsychiatric Interpretative Electroencephalograph Assessment Aid

FDA product code NCG · 2 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1440
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-02-02 – 2025-12-08

Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."

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