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510(k) Data Aggregation

    K Number
    K242750
    Device Name
    Central Station
    Manufacturer
    Nihon Kohden Digital Health Solutions, LLC
    Date Cleared
    2025-06-05

    (266 days)

    Product Code
    MSX, DRQ, MHX, MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nihon Kohden Digital Health Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Central Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. Central Station does not perform any data processing on the data received from the Nihon Kohden compatible devices. When Central Station is connected with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the Central Station can: • Admit and discharge patients on the Nihon Kohden network. • Display and manage compatible devices' real-time patient clinical data, vital signs, alarms and waveforms. • Review and trend data calculated by connected Nihon Kohden devices. • Store and transfer historical clinical data for the connected systems. • Print patient data. Central Station is intended for use in professional medical facilities by trained medical personnel.
    Device Description
    Central Station is software only product that is installed on a Commercial Off the Shelf (COTS) Computer. Central Station displays waveforms data and numerical data from a connected bedside monitor, vital sign telemeter, or multiple patient receiver unit on the screen. Central Station is a network device, intended to provide remote patient monitoring to medical personnel. Central Station displays a list of measured values and a trend graph. Numerical data and various waveforms are color-coded for each parameter. Central Station also has the function of displaying an alarm. Alarm indication in Central Station is displayed as a result of a judgment by the bedside monitor, vital sign telemeter, or multiple patient receiver units connected to the Central Station. Central Station itself does not have the function to perform alarm indication judgment.
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