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510(k) Data Aggregation

    K Number
    K090249
    Device Name
    MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
    Date Cleared
    2009-04-03

    (60 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARBINGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MI-1000 system is used to measure Wavelet Surface Residuum indices at rest and during low level electrical stimulation during the cardiac refractory period. This data is presented in a graphical format for interpretation by a trained physician. The MI-1000 system is also used for the measurement of SAECG indices. The MI-1000 system should be used only as an adjunct to clinical history and the results of other noninvasive and /or invasive tests.
    Device Description
    The device consists of an IBM compatible PC, nine skin surface electrodes, one electronics board, a patient interface module and software. Seven of the electrodes are used for sensing cardiac electrical activity. The remaining two electrodes are used to apply low level current pulses (maximum 40 milliamps) to the patient. This technology uses noninvasive, externally applied, subthreshold (low amplitude) far-field stimulus while acquiring electrocardiogram data.
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    K Number
    K013615
    Device Name
    MICRO-INDUCTION 1000 SYSTEM
    Date Cleared
    2002-05-29

    (205 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARBINGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MI-1000 is used to measure Wavelet Surface Residuan indices at rest and during low level electrical stimulation during the cardiac refractory period. This data is presented in a graphical format for interpretation by a trained physician. The MI-1000 is also used for the measurement of SAECG indices. The MI-1000 should be used only as an adjunct to clinical history and the results of other noninvasive and/or invasive tests.
    Device Description
    The device consists of an IBM compatible PC, nine skin surface ECG type electrodes, one electronics board, a patient interface module and software. Seven of the electrodes are used for sensing cardiac electrical activity. The remaining two electrodes are used to apply low level current pulses (maximum of 40 milliamps) to the patient. This technology uses noninvasive, externally applied, subthreshold (low amplitude) far-field stimulus while acquiring electrocardiogram data. The MI-1000 system is a tool used to identify heart cells that are significantly less stable than normal or conduct slower than normal and, thus, are an indication of cardiac electrical problems.
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