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

    PATHWAY II ELECTROMYOGRAPH

    K Number: K897132 · Decision Apr 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    11
    Review Days
    477

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    Basic Information

    Device Name
    PATHWAY II ELECTROMYOGRAPH
    K Number
    K897132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    The Prometheus Group
    Date Received
    December 27, 1989
    Decision Date
    April 18, 1991
    Product Code
    HCC
    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
    HCC Device, Biofeedback

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