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510(k) Data Aggregation

    K Number
    K051175
    Device Name
    CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
    Manufacturer
    CIVENT COMMUNICATIONS LTD
    Date Cleared
    2006-02-17

    (287 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIVENT COMMUNICATIONS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CIVNET CIV-ob software application is intended for automatic fetal monitor patient data management. The application does this by: a) Displaying on-line fetal heart rate and TOCO data received from the patient Displaying on mic recar near representation as it is displayed on the fetal monitor paper printout. b) Providing the means to control and display multiple beds simultaneously. c) Providing automatic Archiving of the data. c) Frovide the ability to interface with different fetal monitors operating with the same interface protocol. e) Easy interfacing with any IT patient record system for data acquisition, viewing and storage of electronic patient record. f) Provide visual notification of when acquired fetal monitor heart rate exceed I to ride visual nothlous for high and low fetal heart rate and poor signal quality. g) Providing the ability to record, with patient record, fluid input and output information that is defined by the user. h) Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk). Providing the ability to print (locally or remote) patient records. i) i) I roviding the ability to review fetal monitor data remotely over the TCP/IP
    Device Description
    The CIVNET CIV-ob is a software application that is intended for use as a clinical data management system (also referred to as a clinical information system - CIS). The function of the system is the management of fetal and maternal vital heart rate and uterine vital signs clinical data automatically acquired from a bedside fetal monitor, for the purpose of providing, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The CIV-ob serves as an electronic medical record. The CIV-ob operates with off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.
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