Product Classification

• Device: amplitude-integrated electroencephalograph
• Regulation Description: Electroencephalograph.
• Definition: Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
• Physical State: May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, more complex software used to analyze the amplitude-integrated electroencephalograph signal, software used to automatically detect events, electroencephalograph used for polysomnography or sleep studies, or standard electroencephalograph (full- or reduced- montage).
• Technical Method: Uses a specific combination of filters, a semi-logarithmic scale and bipolar electrode placements (via user-specified and/or sponsor-specified locations), to record and display electrical activity of the brain.
• Target Area: Brain
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: OMA
• 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 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