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510(k) Data Aggregation

    K Number
    K071953
    Device Name
    RTX3370
    Manufacturer
    RTX HEALTHCARE A/S
    Date Cleared
    2007-08-08

    (23 days)

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

    RTX HEALTHCARE A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RTX3370 is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The RTX3370 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management centre or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line. The RTX3370 does not measure, interpret or make any decisions on the vital data that it conveys.
    Device Description
    The RTX3370 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The RTX3370, with its build-in modem, transmits data using the public switched telephone network. The RTX3370 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons The RTX3370 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
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    K Number
    K062304
    Device Name
    DLM112 DAYLINK MONITOR
    Manufacturer
    RTX HEALTHCARE A/S
    Date Cleared
    2006-09-29

    (52 days)

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

    RTX HEALTHCARE A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daylink 112 Monitor ("DLM112") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM112 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line. The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.
    Device Description
    The DLM112 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The DLM112, with its build-in modem, transmits data using the public switched telephone network. The DLM112 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons The DLM112 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
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    K Number
    K041816
    Device Name
    RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
    Manufacturer
    RTX HEALTHCARE A/S
    Date Cleared
    2004-07-19

    (13 days)

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

    RTX HEALTHCARE A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RTX3320 device is for use by patients at home. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center, or with the healthcare/wellness provider or other out-of-hospital caregivers. The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line. RTX3320 is a "black box" device – it is not connected to the patient and not operated by the patient. The installation must be performed by or under supervision of an authorized professional healthcare company. This device does not measure, interpret or make any decisions on the vital data that it conveys.
    Device Description
    The RTX3320 telemedicine device perform transmission of physiological patient information to and from wireless patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The RTX3320, with its build-in modem, transmits data using the public switched telephone network. It is designed not to interfere with the normal use of phones on the same telephone line. The RTX3320 device is not operated by, or used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
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