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510(k) Data Aggregation

    K Number
    K153335
    Device Name
    AlertWatch: OR
    Manufacturer
    ALERTWATCH LLC
    Date Cleared
    2016-03-15

    (117 days)

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

    ALERTWATCH LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision. AlertWatch:OR is also intended for use by supervising anesthesiologists outside of operating rooms. Once alerted, the supervising anesthesiologist must contact the clinician inside the operating room or must return to the operating room before making a clinical decision. Once either clinician is alerted, they must refer to the primary monitor or device before making a clinical decision.
    Device Description
    AlertWatch:OR is a display and secondary alert system used by the anesthesiology staff residents. CRNA's, and attending anesthesiologists - to monitor patients in operating rooms. The purpose of the program is to synthesize a wide range of patient data and inform clinicians of potential problems that might lead to immediate or long-term complications. Once alerted, the clinician is instructed to refer to the primary monitoring device before making a clinical decision. AlertWatch:OR should only be connected to AIMS systems and physiologic monitors that have been validated for use with AlertWatch:OR. AlertWatch, LLC performs the validation for each installation site. The purpose of this 510(k) is for marketing clearance of AlertWatch:OR 2.50 which includes minor modifications to some display views, user features, indicators and alerts as well as compatibility with the iPad and the iPhone.
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    K Number
    K130401
    Device Name
    ALERTWATCH: OR
    Manufacturer
    ALERTWATCH LLC
    Date Cleared
    2014-02-07

    (353 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALERTWATCH LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.
    Device Description
    AlertWatch:OR is a display and secondary alert system used by the anesthesiology staff - residents, CRNA's, and attending anesthesiologists - to monitor patients in operating rooms. The purpose of the program is to synthesize a wide range of patient data and inform clinicians of potential problems that might lead to immediate or long-term complications. Once alerted, the clinician is instructed to refer to the primary monitoring device before making a clinical decision. AlertWatch:OR should only be connected to AIMS systems and physiologic monitors that have been validated for use with Alert Watch:OR. Alert Watch, Inc. performs the validation for each installation site.
    Ask a Question

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