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

    NEUROVISION NERVE LOCATOR MONITOR

    K Number: K110140 · Decision Sep 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    9
    Review Days
    255

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    Basic Information

    Device Name
    NEUROVISION NERVE LOCATOR MONITOR
    K Number
    K110140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurovision Medical Products, Inc.
    Date Received
    January 18, 2011
    Decision Date
    September 30, 2011
    Product Code
    GWF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWF Stimulator, Electrical, Evoked Response

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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
    K110989 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
    K110712 DRYTOUCH SUCTION STIMULATOR PROBE
    K110138 PAIRED HYDROGEL ELECTRODE
    K102862 NEUROVISION SE (NERVEANA)