Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K201747
    Device Name
    8-CH Electroencephalography Amplifier
    Date Cleared
    2020-12-27

    (184 days)

    Product Code
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    HippoScreen Neurotech Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 8-CH Electroencephalography Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.
    Device Description
    8-CH Electroencephalography Amplifier capture brain wave signals through non-invasive electrodes, amplify the analog signals and convert to digital signals for computer use. The EEG monitoring panel can immediately display patient's brain wave to assure signal quality of testing requirements. Begin to test when signal quality lamp on EEG monitoring panel shows green light.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1