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510(k) Data Aggregation

    K Number
    K041409
    Device Name
    MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
    Manufacturer
    Date Cleared
    2004-08-20

    (85 days)

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

    INOMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Micro - recording and stimulation electrodes are intended to be used in the human brain for the recording of Neuro potentials of single brain cells and for electrical stimulation of small areas in the brain.
    Device Description
    MicroMacroelectrodes are equipped with a micro tip and a MacroElectrode. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for If acca to tol sion. The macro tip is used for stimulation and recording of local field potentials. MacroElectrodes are monopolar electrodes equipped with an active macro tip. They are used for stimulation and recording of local field potentials. Micro Electrodes are monopolar electrodes equipped with a micro tip. They are used for recording cell potentials of single cells or cell clusters and for Microstimulation. They are similar to MicroMacroelectrodes but without the Macroelectrode.
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