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510(k) Data Aggregation

    K Number
    K060756
    Device Name
    MEDLOG, MODEL 1-0-10
    Date Cleared
    2006-10-30

    (223 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMC GESELLSCHAFT FUR MEDIZINTECHNIK MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEDLOG System is indicated for the use in data collection and clinical information management. MEDLOG is connected with independent and onlinedial or clinical devices either directly of through networks. MEDLOG is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices, which is connected to.
    Device Description
    MEDLOG is based of open-architecture design using JAVA Technology. MEDLOG is a data acquisition and distribution software. It retrieves data from serial or network devices and makes thes data available over networks or any other type of communication for us in software applications. BMC customers can buy cables and can connect the devices directly to the COM Port or they can use a multiport box. Customers also can use Serial/Ethernet converters if needed. BMC not recommends hardware suppliers. MEDLOG enables the interfacing of medical devices, which are types of blood-gas analyzers or cardiac-monitoring systems. It is a matter of principle, that MEDLOG is able to support other kind of connected devices. The basic componente of MEDLOG ist the MCS Communication server, which runs and controls MMD Device Drivers. The collected device data can stored temporarily may MCS. The MEI External Interfaces makes data available for other external systems.
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