LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060756
    Device Name
    MEDLOG, MODEL 1-0-10
    Manufacturer
    BMC GESELLSCHAFT FUR MEDIZINTECHNIK MBH
    Date Cleared
    2006-10-30

    (223 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K032142
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves device performance, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

    The document is a 510(k) summary for the MEDLOG device, which is a data collection software. It primarily focuses on demonstrating substantial equivalence to a predicate device (DataCaptor Software, K032142) by comparing their indications of use, interfaces, where used, and computer compatibility. The key difference highlighted is the technology used (JAVA for MEDLOG vs. Windows/DCOM for DataCaptor).

    Therefore, I cannot provide the requested table and study details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1