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

    HILGER DUAL-STIM NERVE STIMULATOR

    K Number: K063560 · Decision Jan 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    6
    Review Days
    38

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    Basic Information

    Device Name
    HILGER DUAL-STIM NERVE STIMULATOR
    K Number
    K063560
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wr Medical Electronics Co.
    Date Received
    November 28, 2006
    Decision Date
    January 5, 2007
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETN Stimulator, Nerve

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