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    K Number
    K250922
    Device Name
    Edema Guard Monitor (EGM) CardioSet-001
    Manufacturer
    CardioSet Medical Ltd.
    Date Cleared
    2025-09-09

    (166 days)

    Product Code
    DSB
    Regulation Number
    870.2770
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K133301
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EGM CardioSet-001 is intended for patients with any of the following conditions:

    • With fluid management problems
    • Taking diuretic medication
    • Living with heart failure
    • Suffering or recovering from a coronary artery disease-related event

    This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in both the inpatient and outpatient setting.

    The EGM CardioSet-001 reading is intended to be used as an adjunct parameter to standard clinical assessment methods and should not be the sole input used to guide treatment.

    Device Description

    The Edema Guard Monitor (EGM) CardioSer-001 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 EGM CardioSet-001 works by applying a low amplitude, high frequency electrical current to the body and measuring the electrical impedance. By separately monitoring the impedance of various electrode pairs, the impedance due to the thoracic cavity can be isolated, improving device sensitivity. Base Impedance decreases when fluid increases and increases when fluid decreases.

    The EGM CardioSet-001 is designed for use with commercially available electrodes which are positioned with the assistance of the supplied templates.

    AI/ML Overview

    N/A

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