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510(k) Data Aggregation

    K Number
    K061328
    Device Name
    THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
    Manufacturer
    E-SAN LIMITED
    Date Cleared
    2006-06-13

    (32 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    E-SAN LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The e-San Bluetooth Cradle is intended to be used by patients at home. It is physically connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and wirelessly sends the signals (via Bluetooth V1.2) to a Bluetooth enabled cellular phone such as the Nokia 6230. The e-San Bluetooth Cradle serves as the remote communication link between the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and a cellular telephone. The t+ Diabetes System enables users to store and display data on the cellular phone, and to send data from the cellular telephone to a remote database for storage and display via the internet.
    Device Description
    The e-San Bluetooth Cradle is connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and uses short-range low power wireless transmission (Bluetooth V1.2) to send the data to a Bluetooth compatible cellular telephone such as the Nokia Model 6230. The t+ Diabetes System allows the blood glucose data to be stored and displayed on a cell phone, and transmitted to a centralized database for storage and display.
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    K Number
    K052343
    Device Name
    E-SAN BLUETOOTH CRADLE
    Manufacturer
    E-SAN LIMITED
    Date Cleared
    2005-12-07

    (103 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    E-SAN LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The e-San Bluetooth Cradle is intended to be used by patients at home. It is physically connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and wirelessly sends the signals (via Bluetooth V1.2) to a Bluetooth enabled cellular phone such as the Nokia 6230. The e-San Bluetooth Cradle serves as the remote communication link between the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and a cellular telephone.
    Device Description
    The device is the e-San Bluetooth Cradle and it is connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and uses short-range low power wireless transmission (Bluetooth V1.2) to send the data to a Bluetooth compatible cellular telephone such as the Nokia Model 6230. The Cradle is battery powered and fits over and plugs into a 3.5 mm 3-wire stereo socket that is in the end of the OneTouch® Ultra® device.
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