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U.S. Department of Health and Human Services

Product Classification

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Device automatic event detection software for polysomnograph with electroencephalograph
Regulation Description Electroencephalograph.
Definition Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
Physical State Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, polysomnograph hardware, or basic electroencephalograph/polysomnograph software (e.g. used to display, store, archive, or manually annotate data).
Technical Method Uses software algorithms to analyze electroencephalograph and polysomnograph waveforms and automatically identify areas of interest to the user
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOLZ
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