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510(k) Data Aggregation

    K Number
    K103214
    Device Name
    M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
    Manufacturer
    LIFELINE SYSTEMS, INC.
    Date Cleared
    2010-12-01

    (30 days)

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

    LIFELINE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The M3810A Philips TeleMonitoring System with eDevice BridgeD130 is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines or cellular connectivity, between a patient, typically at home, and a health care professional at the authorized provider. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered. The M3810A Philips TeleMonitoring System with eDevice BridgeD130 is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines or cellular connectivity to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
    Device Description
    The M3810A Philips Telemonitoring System with eDevice BridgeD130 is a system that automatically collects and transmits medical information such as weight, blood pressure, and non-diagnostic ECG from a patient at home to a healthcare professional. The eDevice BridgeD130 is an external wireless communication device that transmits data to the backend clinical server.
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