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510(k) Data Aggregation

    K Number
    K082404
    Device Name
    NAVIGATION PROBES
    Manufacturer
    Date Cleared
    2009-02-25

    (188 days)

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

    WE SENSE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    We Sense Navigation Probes electrodes are intended to be used in operation room during neurosurgery for temporary (less than two hours) recording and stimulation of defined small area in the brain, and for recording electrical signals from target brain cells. These electrodes can be used only by professional staff and not sell over the counter
    Device Description
    NavigationProbes are equipped with a Micro tip and a Macro tip. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for MicroStimulation. The Macro tip is used for stimulation and recording of local field potentials.
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