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510(k) Data Aggregation

    K Number
    K142503
    Device Name
    IMED-Z FLUID STATUS MONITOR
    Manufacturer
    INTERSECTION MEDICAL, INC.
    Date Cleared
    2015-06-05

    (273 days)

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

    INTERSECTION MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMED-Z Fluid Status Monitor is intended for patients: - With fluid management problems - Taking diuretic medication - Living with Heart Failure ● - Living with End-stage Renal Disease ● - Recovering from Coronary artery Disease related event ● - o Suffering from Recurrent Dehydration This device is intended for use, under the direction of a physician, for the noninvasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
    Device Description
    The IMED-Z Fluid Status Monitor is a non-invasive, battery-powered impedance monitor designed as an "early warning" monitor for determining changes in the fluid status of patients with fluid management problems. The IMED-Z Fluid Status Monitor works by applying a low-amplitude, high frequency electrical current to the body and measuring the electrical impedance using a four-point measurement technique through hydrogel (ECG style) electrode contacts. Base Impedance, also known as Zo, decreases when fluid increases and increases when fluid decreases. The Fluid Status Monitor is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available from Intersection Medical, Inc. IMED-approved electrodes must be used with the IMED-Z Fluid Status Monitor. Zo reading obtained from unapproved electrodes may not be accurate.
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