title: Medical devices; neurological devices; classification of the neuropsychiatric interpretive electroencephalograph assessment aid. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the neuropsychiatric interpretive electroencephalograph (EEG) assessment aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D004569:Electroencephalography / Q000145:classification* / Q000295:instrumentation*; D006801:Humans; D009462:Neurology / Q000145:classification* / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D012984:Software / Q000145:classification* / Q000331:legislation & jurisprudence; D014481:United States