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510(k) Data Aggregation

    K Number
    K133252
    Device Name
    HEALTHINTERLINK BEACON
    Date Cleared
    2014-03-14

    (143 days)

    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHINTERLINK, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HealthInterlink® Beacon® device is for use by patients to collect and transmit general health information, physiological measurements such as blood pressure, weight, glucose and SpO2 using commercially available FDA cleared wireless medical devices designed for home use, and other data between themselves and a caregiver. The HealthInterlink® Beacon® makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. HealthInterlink® Beacon® is not intended as a substitute for medical care.
    Device Description
    The HealthInterlink Beacon is a software application. Once installed on a commerciallyavailable device, the HealthInterlink Beacon software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted to a server database for review by a caregiver. The HealthInterlink Beacon software has a user interface which allows the patient and caregiver to communicate using methods which include questions, answers, and messages. HealthInterlink Beacon is not intended for emergency use or real-time monitoring.
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