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U.S. Department of Health and Human Services

Product Classification

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Device normalizing quantitative electroencephalograph software
Regulation Description Electroencephalograph.
Definition Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Physical State Electroencephalograph analysis software. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, software that compares data to non-normative databases, software that does not compare to a normative database or electroencephalograph software that outputs an Index, classification, diagnosis or any clinical interpretation of the data.
Technical Method Uses software algorithms as a tool to analyze electroencephalograph (from user-specified electrode number and locations) and automatically calculates conventional electroencephalograph parameters. (e.g. power, asymmetry, coherence) and normalizes the data by comparison to a normative database; output is a z-score, standard deviation or some other quantification of difference between subject and normative values.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOLU
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
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