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510(k) Data Aggregation

    K Number
    K043549
    Device Name
    INFINITY GATEWAY SUITE, VF4
    Manufacturer
    Draeger Medical Systems, Inc.
    Date Cleared
    2005-01-21

    (29 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K014213,K030657
    Why did this record match?
    Device Name :

    INFINITY GATEWAY SUITE, VF4

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

    The Infinity MultiView WorkStation, Infinity Network and Remote Display are intended for use as a central monitoring device, communications network, and remote display for Draeger patient monitoring systems and recorders.

    The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

    Device Description

    The Infinity Gateway Suite (K014213/K030657) is a server-based software application that provides a connection to the Infinity Network and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.

    Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:

    • . Server Software
    • . Interface Software Options
    • Developers Tools .
    • Remote View Applications 해
    • . Pager Interface

    The primary modification included in the VF4 software release of the Infinity Gateway Suite is the visual display of alarms on WinView and WebViewer.

    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, or any studies conducted on the Infinity Gateway Suite. The document is a 510(k) summary and FDA clearance letter, which describes the device, its intended use, and indicates that verification and validation testing was performed to establish equivalence to previous versions, but does not provide details of such testing or specific performance metrics.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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