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510(k) Data Aggregation

    K Number
    K083331
    Device Name
    CONFIDANT, MODEL 2.6
    Manufacturer
    CONFIDANT INC.
    Date Cleared
    2009-01-09

    (58 days)

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

    CONFIDANT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Confidant 2.6 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health. Confidant 2.6 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard communication technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient, via cell-phone or personal computer. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data. Confidant 2.6 does not provide diagnosis of any disease or medical condition. Confidant 2.6 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. Confidant 2.6 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention. Confidant 2.6 is intended for over-the-counter use.
    Device Description
    Confidant 2.6 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard communication technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient, via cell-phone or personal computer. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data. Confidant 2.6 currently supports several models of glucose meters, a non-invasive blood pressure cuffs and a weight scale.
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    K Number
    K072698
    Device Name
    CONFIDANT 2.5
    Manufacturer
    CONFIDANT INC.
    Date Cleared
    2007-11-16

    (53 days)

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

    CONFIDANT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health. Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data. Confidant 2.5 does not provide diagnosis of any disease or medical condition. Confidant 2.5 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. Confidant 2.5 is not intended for emergency calls or for transmission of any real-time alarms or timecritical data. This device is not intended as a substitute for direct medical supervision or emergency intervention. Confidant 2.5 is intended for over-the-counter use.
    Device Description
    Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data. Confidant 2.5 currently supports several models of glucose meters, noninvasive blood pressure cuffs and weight scales.
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    K Number
    K062215
    Device Name
    CONFIDANT 2.0
    Manufacturer
    CONFIDANT INC.
    Date Cleared
    2006-10-16

    (76 days)

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

    CONFIDANT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Confidant 2.0 is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. Confidant 2.0 is to be used only upon prescription of a licensed physician or other authorized healthcare provider. Confidant 2.0 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention. Confidant 2.0 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
    Device Description
    Confidant 2.0 is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Confidant 2.0 currently supports several models of glucose meters, non-invasive blood pressure cuffs and weight scales.
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