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510(k) Data Aggregation

    K Number
    K192732
    Device Name
    BodyGuardian Remote Monitoring System
    Manufacturer
    Preventice Technologies, Inc.
    Date Cleared
    2020-03-26

    (181 days)

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

    Preventice Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, in-hospital monitoring for life threatening arrhythmias. The Preventice BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, weight scales, blood pressure meters and pulse oximeters, and parameters such as ECG, heart rate, body weight, temperature, respiration rate, blood pressure, and SpO2. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.
    Device Description
    Arrhythmia Detector and Alarm; Patient Physiological Monitor (with arrhythmia detection) The predicate device's ECG Unit is a small, ambulatory cardiac monitor that records and transmits ECG data. The subject device's ECG Unit is also a small, ambulatory cardiac monitor that records and transmits ECG data. Both products, the predicate and subject devices, provide a data hub function that connects to commercially available devices such as weight scales, blood pressure monitors, pulse oximeters, ECG Units and other plug-in devices. For both devices, the predicate and subject devices, data is transmitted to an external device or server, depending model. If not a server, this device sends the data to a remote computer server that allows healthcare professionals to access and review the data.
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    K Number
    K151188
    Device Name
    BodyGuardian Remote Monitoring System
    Manufacturer
    PREVENTICE
    Date Cleared
    2015-09-17

    (136 days)

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

    PREVENTICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias. The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.
    Device Description
    The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias. The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.
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    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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