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510(k) Data Aggregation

    K Number
    K151672
    Device Name
    Cerner CareAware Event Management
    Manufacturer
    Date Cleared
    2015-12-21

    (182 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERNER CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points. Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alarm notification is the device or system producing the alarm or event. This device is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices. CareAware Event Management™ is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does CareAware Event Management™ come into direct contact with patients.
    Device Description
    CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.
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