Product Classification

• 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 Code: OLU
• 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc