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

    COMPUTERSCOPE CPS-ABR

    K Number: K833413 · Decision Nov 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    COMPUTERSCOPE CPS-ABR
    K Number
    K833413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Rc Electronics, Inc.
    Date Received
    September 30, 1983
    Decision Date
    November 28, 1983
    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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