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510(k) Data Aggregation

    K Number
    K210160
    Device Name
    AlertWatch:AC
    Manufacturer
    AlertWatch, Inc.
    Date Cleared
    2021-09-10

    (232 days)

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

    AlertWatch, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlertWatch:AC is intended for use by physicians for secondary monitoring of ICU patients. AlertWatch:AC is also intended for use by physicians providing supplemental remote support to bedside care teams in the management and care of ICU patients. AlertWatch:AC is not intended for use in monitoring pediatric or neonatal patients. AlertWatch:AC is a software system that combines data from the electronic medical record, networked physiologic monitors, and ancillary systems, and displays them on a dashboard view of the unit and patient. The clinical decision support is generated to aid in understanding the patient's current condition and changes over time. Once alerted by AlertWatch:AC, the physician must refer to the primary monitor, device or data source before making a clinical decision.
    Device Description
    AlertWatch:AC is a secondary monitoring system used by physicians to monitor adult patients in an ICU environment. The purpose of the device is to synthesize a wide range of patient data and inform physicians of potential problems. Once alerted, the physician is instructed to refer to the primary monitoring device or EMR before making a clinical decision. The software design includes a default set of rules and alerts that can be configured by the hospital during the installation process. AlertWatch:AC is intended to supplement, not replace, a hospital's primary EMR. The device retrieves data from the electronic medical record (EMR) system and networked physiologic monitors, integrates this data, and performs a series of calculations to assess potential clinical issues. The information is conveyed both via organ colors and messages in the alert panel. Any alert can also be configured to send pages to physicians assigned to the patient.
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    K Number
    K173715
    Device Name
    AlertWatch:OB
    Manufacturer
    AlertWatch, Inc.
    Date Cleared
    2018-04-23

    (140 days)

    Product Code
    HGM, MWI
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    AlertWatch, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlertWatch:OB is intended for use by clinicians for secondary monitoring of maternal patients in the labor and delivery unit. AlertWatch:OB is a maternal surveillance system that combines data from validated electronic medical record systems, and displays them in one place. Once alerted by AlertWatch:OB, the clinician must refer to the primary monitor, device, or data source before making a clinical decision.
    Device Description
    AlertWatch:OB is a secondary monitoring system used by OB nurses, obstetricians, and OB anesthesiologists to monitor women in the Labor and Delivery (L&D) unit. The purpose of the program is to synthesize a wide range of maternal patient data and inform clinicians of potential problems. Once alerted, the clinician is instructed to refer to the primary monitoring device or EMR before making a clinical decision. AlertWatch:OB should only be connected to EMR systems that have been validated for use with AlertWatch:OB. AlertWatch, LLC performs the validation for each installation site.
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