BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    8-CH Electroencephalography Amplifier

    K Number: K201747 · Decision Dec 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    184

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    Basic Information

    Device Name
    8-CH Electroencephalography Amplifier
    K Number
    K201747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hipposcreen Neurotech Corp.
    Date Received
    June 26, 2020
    Decision Date
    December 27, 2020
    Product Code
    GWL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWL Amplifier, Physiological Signal

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