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

    MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT

    K Number: K012069 · Decision Aug 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
    K Number
    K012069
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurotron Medical, Inc.
    Date Received
    July 2, 2001
    Decision Date
    August 1, 2001
    Product Code
    JXE
    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
    JXE Device, Nerve Conduction Velocity Measurement

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