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

    AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

    K Number: K050194 · Decision Apr 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    52
    Applicant Total
    15
    Review Days
    89

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    Basic Information

    Device Name
    AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
    K Number
    K050194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1350
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axon Systems, Inc.
    Date Received
    January 27, 2005
    Decision Date
    April 26, 2005
    Product Code
    GXZ
    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
    GXZ Electrode, Needle

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