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510(k) Data Aggregation

    K Number
    K133301
    Device Name
    ZOE FLUID STATUS MONITOR
    Manufacturer
    NONINVASIVE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2014-01-22

    (89 days)

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

    NONINVASIVE MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZOE 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, Suffering from Recurrent Dehydration. 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 a variety of medically accepted clinical applications.
    Device Description
    The ZOE Fluid Status Monitor Model ZOE3 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 ZOE Fluid Status Monitor Model ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor Model ZOE3 is designed for use with disposable, self-adhesive silver i silver chloride electrodes that are readliy available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!
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    K Number
    K131509
    Device Name
    ZOE FLUID STATUS MONITOR
    Manufacturer
    NONINVASIVE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2013-06-28

    (35 days)

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

    NONINVASIVE MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZOE 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 . - Suffering from Recurrent Dehydration . 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 a variety of medically accepted clinical applications.
    Device Description
    The ZOE 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 ZOE Fluid Status Monitor works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!
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    K Number
    K112830
    Device Name
    ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
    Manufacturer
    NONINVASIVE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2012-11-13

    (412 days)

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

    NONINVASIVE MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZOE 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 - Suffering from Recurrent Dehydration 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 a variety of medically accepted clinical applications.
    Device Description
    The ZOE 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 ZOE Fluid Status Monitor works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver chloride electrodes that are readly available / commercially approved within the United States for other approved cardiovascular monitoring systems.
    Ask a Question

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