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

    NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

    K Number: K110989 · Decision Nov 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    9
    Review Days
    209

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    Basic Information

    Device Name
    NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
    K Number
    K110989
    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
    Neurovision Medical Products, Inc.
    Date Received
    April 8, 2011
    Decision Date
    November 3, 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 Neurovision Medical Products, Inc.

    K Number Device Name
    K130570 NEUROVISION MEDICAL MOTION SENSOR
    K130806 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
    K113771 SIGNAL GEAR URETHRAL CATHETER ELECTRODE
    K121931 NONDISPOSABLE STIMULATING INSTRUMENTS
    K110140 NEUROVISION NERVE LOCATOR MONITOR
    K110712 DRYTOUCH SUCTION STIMULATOR PROBE
    K110138 PAIRED HYDROGEL ELECTRODE
    K102862 NEUROVISION SE (NERVEANA)