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510(k) Data Aggregation

    K Number
    K051450
    Device Name
    EXTENDED MEASUREMENTS SYSTEM
    Manufacturer
    INOVISE MEDICAL, INC.
    Date Cleared
    2005-11-10

    (161 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K043074
    Why did this record match?
    Device Name :

    EXTENDED MEASUREMENTS SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Extended Measurements System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated COR report for consideration by physicians. In addition the data can be presented in the format of real-time and trended display of cardiac indices derived from simultaneous ECG data and heart sounds data.

    The Extended Measurements System can be used as an add-on device to work in conjunction with an AUDICOR-enabled device, or as a stand-alone electrocardiograph.

    The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.

    The device is intended for use only under the direct supervision of a physician, and is for use on adults (≥ 18 years).

    Device Description

    The Extended Measurements System is a software-based device that that can be installed into a compatible computer to communicate with an AUDICOR-capable device via a Blue tooth interface. The Extended Measurements system will also be offered as a stand-alone electrocardiograph/ monitoring device.

    AI/ML Overview

    The provided text does not contain acceptance criteria or a
    description of a study that proves the device meets acceptance criteria.
    Instead, it is a 510(k) premarket notification summary for the AUDICOR® Extended Measurements System.

    This document focuses on establishing substantial equivalence to a
    predicate device (AUDICOR® 200 system, K043074) based on technological
    characteristics and intended use, rather than presenting a performance
    study against predefined acceptance criteria.

    The "Test Summary & Conclusion" section mentions that the device was
    tested to applicable requirements of certain standards (like ANSI/AAMI EC-11) and shown to comply. However, it does not
    provide details of specific acceptance criteria for performance
    metrics, nor the results of such tests in the context of what you're
    asking for.

    Therefore, I cannot provide the requested table or detailed study
    information as it is not present in the given text.

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