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510(k) Data Aggregation

    K Number
    K121197
    Device Name
    BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
    Manufacturer
    PREVENTICE, INC.
    Date Cleared
    2012-08-10

    (113 days)

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

    PREVENTICE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuardian System detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian System continuously records, stores and periodically transmits the following physiological data to a remote computer server for up to 30 days at a time: • ECG • Heart rate (including HR variability and HR reliability) • Respiration rate • Activity
    Device Description
    The BodyGuardian System is an ambulatory cardiac monitoring system prescribed by healthcare providers. It monitors and records a patient's electrocardiographic (ECG) data, heart rate, respiration rate and activity level. The complete system consists of components that collect data, send the data to a remote Preventice computer server, store the data in secure databases, and present the data for review by healthcare professionals.
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