BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    LARYNGEAL SURFACE ELECTRODE

    K Number: K093373 · Decision Aug 24, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    9
    Review Days
    299

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    Basic Information

    Device Name
    LARYNGEAL SURFACE ELECTRODE
    K Number
    K093373
    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
    Spes Medica Srl
    Date Received
    October 29, 2009
    Decision Date
    August 24, 2010
    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 Spes Medica Srl

    K Number Device Name
    K211954 Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
    K212326 AC Cream - Conductive paste
    K192606 SAC2 - Electrode Cream
    K192603 Spes Medica Subdermal Needle Electrodes
    K190050 Tech Dots - Adhesive and conductive gel
    K133348 STIM PROBE
    K120494 DISPOSABLE ADHESIVE SURFACE ELECTRODE
    K091410 DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,