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U.S. Department of Health and Human Services

Product Classification

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Device amplitude-integrated electroencephalograph
Regulation Description Electroencephalograph.
Definition Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
Physical State May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, more complex software used to analyze the amplitude-integrated electroencephalograph signal, software used to automatically detect events, electroencephalograph used for polysomnography or sleep studies, or standard electroencephalograph (full- or reduced- montage).
Technical Method Uses a specific combination of filters, a semi-logarithmic scale and bipolar electrode placements (via user-specified and/or sponsor-specified locations), to record and display electrical activity of the brain.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOMA
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1400
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
Accredited Persons