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510(k) Data Aggregation

    K Number
    K042113
    Device Name
    ZOE FLUID STATUS MONITOR
    Manufacturer
    NONINVASIVE MEDICAL TECHNOLOGIES, LLC.
    Date Cleared
    2004-09-14

    (40 days)

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

    NONINVASIVE MEDICAL TECHNOLOGIES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZOE™ Fluid Status Monitor is indicated for patients: - With fluid management problems o - Taking diuretic medication o - Living with Heart Failure o - Living with End-stage Renal Disease o - Recovering from Coronary Artery Disease related event o - Suffering from Recurrent Dehydration o The ZOE™ Fluid Status Monitor is contraindicated for use with patients: - With allergies to electrode hydrogel O - Skin sensitivities to electrode hydrogel o - Skin breakdown in areas on the chest where ZOE electrode placement is o required. This device is intended for use by qualified health care practitioners, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
    Device Description
    The ZOE™ Fluid Status Monitor is a non-invasive, battery powered thoracic base impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems. The ZOE works by applying a minimal current to the patient. measuring electrical impedance changes throughout the thorax as aortic blood flow increases and decreases in response to each heartbeat. Base Impedance also known as Zo, decreases when fluid increases and rises when less fluid exists in the chest. This device incorporates a proprietary algorithm to calculate the Zo value. The ZOE is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available / commercially approved within the United States for other approved cardiovascular monitoring systems.
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