BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    SURGICAL STIMULATORS

    K Number: K110422 · Decision May 26, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    13
    Review Days
    101

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    Basic Information

    Device Name
    SURGICAL STIMULATORS
    K Number
    K110422
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Technomed Europe
    Date Received
    February 14, 2011
    Decision Date
    May 26, 2011
    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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    Other Clearances by Technomed Europe

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    K121257 LARYNGEAL ELECTRODE
    K073532 DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
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    K062437 DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
    K050325 DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
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