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510(k) Data Aggregation

    K Number
    K120320
    Device Name
    CONNECTED CARE CLINICAL APPLICATION
    Date Cleared
    2012-08-14

    (194 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERMARK MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clinical Application's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Connected Care Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected. The Clinical Application displays the data and system alerts for review and interpretation by a healthcare professional. The Clinical Application is not intended for emergency use or real-time monitoring.
    Device Description
    The Connected Care Clinical Application is a cloud based, web software system. It is accessed from commercially available PC systems with a web browser and minimum performance specifications consistent with typical PC hardware and equipment specifications. The Clinical Application accepts data from Watermark Patient Monitors. The Connected Care Clinical Application is a medical device data system that receives, stores, and displays data received from Watermark home monitoring devices. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected.
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