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510(k) Data Aggregation

    K Number
    K121208
    Device Name
    OBIX PERINATAL DATA SYSTEM 7.0
    Date Cleared
    2012-06-14

    (55 days)

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

    CLINICAL COMPUTER SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For obstetrical patients, the OBIX Perinatal Data System 7.0 provides health care professionals a method to display and archive electronic fetal monitor data and manage demographic information and documentation. The intended use of the OBIX system is displaying and recording fetal and maternal physiological data obtained from electronic fetal monitors. The OBIX system also has these capabilities: - Monitors fetal and maternal physiological data obtained from standard electronic fetal monitors and accompanying accessories and captures it on permanent storage media. - Displays the monitored data for one or more patients in the patient rooms and at other locations as required by the hospital. - Supports patient management activities, including note entry onto the electronic fetal monitor tracings and into the medical record. - Provides tools that assist clinicians in evaluating fetal heart rate patterns. - Generates flowsheets and graphs based on the notes recorded for the patient. - The optional Registration Interface registers patients in the OBIX system directly from the hospital's admissions system. Patients can also be registered in the OBIX system manually, when necessary. - Displays the Status Board (chalkboard), which shows patient rooms and key data elements in real-time format. The Status Board is typically displayed at one or more central locations, usually at the central nurses' station. - Provides optional remote access to patient monitoring and management activities through off-site workstations connected by a virtual private network (VPN) connection or a secure hospital Web page.
    Device Description
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