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

    PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20

    K Number: K960761 · Decision Aug 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    11
    Review Days
    163

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    Basic Information

    Device Name
    PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
    K Number
    K960761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Prometheus Group
    Date Received
    February 26, 1996
    Decision Date
    August 7, 1996
    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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