BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    THE VENUS SYSTEM

    K Number: K880773 · Decision Aug 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    174

    Basic Information

    Device Name
    THE VENUS SYSTEM
    K Number
    K880773
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    NEUROSCIENTIFIC CORP.
    Date Received
    February 26, 1988
    Decision Date
    August 18, 1988
    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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