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U.S. Department of Health and Human Services

Product Classification

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Device automatic event detection software for full-montage electroencephalograph
Regulation Description Electroencephalograph.
Definition Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
Physical State Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data), or automatic event detection software used as an intermediary step in source-localization analysis.
Technical Method Uses software algorithms to analyze full-montage electroencephalograph (16 electrodes) at user-specified locations and automatically identify areas of interest.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOMB
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 Not Third Party Eligible