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

    REFA, PHYSIOLOGICAL AMPLIFIER

    K Number: K060374 · Decision May 30, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    106

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    Basic Information

    Device Name
    REFA, PHYSIOLOGICAL AMPLIFIER
    K Number
    K060374
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tms International BV
    Date Received
    February 13, 2006
    Decision Date
    May 30, 2006
    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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    Other Clearances by Tms International BV

    K Number Device Name
    K063599 PORTI 7 PHYSIOLOGICAL AMPLIFIER