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510(k) Data Aggregation

    K Number
    K143372
    Device Name
    AWARE
    Date Cleared
    2015-04-02

    (128 days)

    Product Code
    Regulation Number
    870.2300
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    Applicant Name (Manufacturer) :

    AMBIENT CLINICAL ANALYTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AWARE™ is intended for use in the data collection, management and storage of patient information, and is used in conjunction with independent patient bedside devices and Hospital Information Systems connected via a network. This device is indicated for use by health care providing patient care in an ICU and Emergency Department healthcare setting. AWARE is indicated for use in the clinical care of hospitalized adult and pediatric patient (newborn, infant, child, and adolescent) with or at risk of critical illness. AWARE is not an Electronic Medical Record (EMR) application and AWARE use is not intended to replace electronic data management systems utilized by healthcare institutions such as an EMR, LIMS (Laboratory Information Management System), PACS (Picture Archive Communication), patient medical device monitoring and alarm systems. AWARE is not a medical Alarm System and AWARE use is not intended to replace medical Alarm Systems (including monitors) within a healthcare institution. AWARE provides no auditory alerts nor does it provide monitoring and alerting of life threatening situations such as a ventilator disconnection, asystolia, or arthythmia. AWARE provides a visual ICUbased status of events reported from the institutions' source systems to aid in the clinical care decision process.
    Device Description
    AWARE ™ is a stand-alone software product used by professional care providers in ICU and Emergency Department healthcare settings for the presentation, collection, management and storage of patient information. The AWARE application was created based on healthcare provider requirements to provide patient data through the use of an interface with built-in tools, practice surveillance, and decision support. The philosophy behind the system is the following: - Identify and present relevant information from an institution's currently deployed patient . information systems - Bundle related data into discrete systemic organ based packages to facilitate efficient informed ● decision making in a healthcare setting. - Automatically collect and display critical patient data ●
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