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510(k) Data Aggregation

    K Number
    K990683
    Device Name
    AXON MP-1 MICROPOSITIONER
    Manufacturer
    AXON INSTRUMENTS, INC.
    Date Cleared
    1999-11-03

    (245 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXON INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use of the Guideline System 3000 MP-1 Micropositioner are for procedures where a precise placement of probes, such as those used for electrophysiological recording and stimulation, lesioning, or chronic stimulation within the nervous system is required.
    Device Description
    The MP-1 Micropositioner is a three-axis positioning device for precise manipulation of probes or electrodes in stereotactic neurosurgical procedures. The "x" and "y" axes are driven by simple micrometer screws, while the "z" or depth axis is driven by a motorized lead-screw arrangement. The positioner allows for the accurate placement of probes within the three dimensional stereotactic space once it has been mounted on a legally marketed stereotactic frame.
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    K Number
    K970943
    Device Name
    GUIDELINE SYSTEM
    Manufacturer
    AXON INSTRUMENTS, INC.
    Date Cleared
    1997-08-18

    (157 days)

    Product Code
    GZL, 84G
    Regulation Number
    882.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXON INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To record from and stimulate brain motor and sensory neurons to aid in the placement of depih electrodes.
    Device Description
    Not Found
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    K Number
    K971318
    Device Name
    MM-1 MOVEMENT MONITOR
    Manufacturer
    AXON INSTRUMENTS, INC.
    Date Cleared
    1997-07-28

    (110 days)

    Product Code
    GYD, 84G
    Regulation Number
    882.1950
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXON INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MM-1 provides useful, quantitative measurements of several neurologically relevant movement phenomena: tremor, dexterity and reaction/movement time. The MM-1 can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease.
    Device Description
    Movement Monitor (MM-1)
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