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510(k) Data Aggregation

    K Number
    K080941
    Device Name
    BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
    Manufacturer
    Date Cleared
    2009-06-18

    (441 days)

    Product Code
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    N.I. MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NICaS CS is intended to monitor and display a patients hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, total peripheral resistance, and the Granov-Goor Index), in males and females with known or suspected cardiac disorders needing cardiac assessment.
    Device Description
    The NICaS (non-invasive cardiac system) CS is a CD-ROM shaped device which replaces the actual CD-Rom of a laptop computer. It is used for noninvasive cardiac diagnostic purposes, The NICaS (non-invasive cardiac system) CS is an impedance device which is unique in its use of a laptop computer as part of a technology for noninvasively measuring the cardiac output and its derivatives. The NICaS is also unique in that it is the only method of impedance cardiography (ICG) which utilizes only two pairs of impedance electrodes, placed on two limbs, preferably one pair on the wrist, and the other on the contra-lateral ankle. This type of electrical surveillance is called regional ICG, or RIC. The NICaS is a tetrapolar apparatus which operates by an alternating current of 1.4 mA and 32 kHZ. The principle of this technology is based on the fact that the electrical conductance of the blood is higher than that of the surrounding tissue structures. Consequently, with each arterial systolic expansion (pulsation), an increase in the electrical conductance (or reduction in the electrical resistance) of the body is measured. This systolic resistance (impedance) change is termed ΔR, and the baseline body resistance is R (Ω). The analog resistance signals are received by the device, where they are amplified and filtered. These signals are then transmitted to a microprocessor, where they are digitized and analyzed via mathematical algorithms.
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