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U.S. Department of Health and Human Services

Product Classification

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Device neuropsychiatric interpretative electroencephalograph assessment aid
Regulation Description Neuropsychiatric interpretive electroencephalograph assessment aid.
Definition 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."
Physical State Software
Technical Method Software analysis of EEG signals
Target Area Software
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNCG
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1440
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible