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510(k) Data Aggregation

    K Number
    K140680
    Device Name
    LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
    Manufacturer
    Date Cleared
    2014-12-12

    (269 days)

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

    ALPINE BIOMED APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Leadpoint Focus microelectrode targeting system is intended to assist in neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes. The Leadpoint Focus microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.
    Device Description
    Intraoperative microelectrode recording (MER) has been introduced to improve the target localization during stereotactic surgery. The Leadpoint Focus is a MER system which consists of the Leadpoint Focus Software, Focus Hardware, a Macro Stimulator, a MER amplifier and a sterile interconnection cable (MER Cable) that connects the system to a Microelectrode. The Microelectrode is supplied by another manufacturer and is not part of the Leadpoint Focus system.
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