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U.S. Department of Health and Human Services

Product Classification

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Device index-generating electroencephalograph software
Regulation Description Electroencephalograph.
Definition Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Physical State Electroencephalograph analysis software, either developed by 510(k) holder for use in their own hardware or licensed from another company for use in 510(k) holder's hardware. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, electroencephalograph software with comparative databases (normal or otherwise) or electroencephalograph software that outputs a diagnosis or classification.
Technical Method Uses software algorithms, developed from and trained with specific patient datasets, to analyze electroencephalograph from 1 to 16 electrodes at sponsor-specified locations; also may output one or several signal quality indicators
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOLW
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