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510(k) Data Aggregation

    K Number
    K173460
    Device Name
    NeuroEEG
    Manufacturer
    Date Cleared
    2018-02-16

    (101 days)

    Product Code
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MemoryMD Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NeuroEEG is intended for prescription use to acquire, record, transmit, and display electrical brain activity of patients of all ages.
    Device Description
    "NeuroEEG" is a 16-lead electroencephalograph. Electrodes correspond to the international 10-20 standard. It is a portable, non-sterile, non-invasive, non-radiation emitting electroencephalogram (EEG) device that works with a stationary PC with uninterruptible power supply (UPS) or a laptop with an internal battery. Signal transfer occurs between NeuroEEG and PC via wireless Bluetooth channel. The accompanying MemoryMD software runs on the Windows operating system (OS) Windows 8.1 and later. This device will be used "By Prescription" pursuant to 21 CFR 801 Subpart D. The medical use of data acquired by "NeuroEEG" is to be performed under the direction and interpretation of a licensed medical professional. This device does not provide any diagnostic conclusion about a subject's condition. The generated data serves as an assessment aid at medical practices, rehabilitation institutions, diagnostic centers, neurosurgical clinics, OR, ICU, ER, and clinical research institutes.
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