Central Station

Central Station is a software-only network device installed on commercial computers that displays, records, and prints physiological data from Nihon Kohden bedside monitors, telemetry receivers, and transmitters. It enables remote patient monitoring in professional medical facilities by showing real-time waveforms, vital signs, alarms, and trends calculated by connected devices, without performing independent data processing.

Central Station has identical intended use and technological characteristics to the predicate CNS-2101 Central Monitor, including the same display (1,920×1,080 resolution 23.8-inch LCD), operating system (Microsoft Windows 10 IoT), network communication protocol (NET-9/LS-NET), and functional capabilities. The main differences are 512GB versus 480GB storage capacity and external versus internal battery backup, neither of which raises safety or effectiveness concerns.

Not stated in this summary.

Central Station is substantially equivalent because it shares the same intended use (displaying, recording, and printing monitored physiological data from Nihon Kohden devices), the same regulatory classification (Class II, 21 CFR 870.2300), and the same technological characteristics as predicate K223567. Both devices perform identical network monitoring functions without independent data processing, support the same compatible monitors and equipment, and provide equivalent display windows and data storage capabilities. Software verification testing and cybersecurity risk management were conducted per FDA guidance and showed the device addresses user needs without raising new safety or effectiveness concerns.