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

    LARYNGEAL ELECTRODE

    K Number: K121257 · Decision Aug 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    13
    Review Days
    124

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    Basic Information

    Device Name
    LARYNGEAL ELECTRODE
    K Number
    K121257
    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
    April 26, 2012
    Decision Date
    August 28, 2012
    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

    K Number Device Name
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    K130136 DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
    K110422 SURGICAL STIMULATORS
    K073532 DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
    K072016 CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE
    K063729 DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
    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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