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

    MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

    K Number: K013215 · Decision Oct 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    91
    Review Days
    20

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    Basic Information

    Device Name
    MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
    K Number
    K013215
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuvasive, Inc.
    Date Received
    September 26, 2001
    Decision Date
    October 16, 2001
    Product Code
    BXM
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BXM Stimulator, Nerve, Ac-Powered

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