Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)

The Pulse Oximeter (FS20P, FS20C, FS10C) is a handheld, battery-powered device that measures oxygen saturation (SpO2) and pulse rate by placing a fingertip into a photoelectric sensor. The FS20P is intended for spot-checking in adolescent, child, and infant patients, while the FS20C and FS10C are for adult patients in hospitals, hospital-type facilities, and homecare. The device is not intended for continuous monitoring, use during motion, or with low perfusion.

The subject device uses transmittance optical sensors at wavelengths of 660 nm (red) and 905 nm (infrared), identical to the predicate. Components include power supply, detector and emitter LED, signal processing module (MCU), OLED or LED display, and button control. It is powered by 2×AAA alkaline batteries and displays SpO2 (0–100% range with 70–100% measurement accuracy ±2%) and pulse rate (25–250 bpm ±3 bpm). Materials include ABS enclosure, PC lens, and silica gel fingertip cushion.

Biocompatibility per ISO 10993-1; bench testing per IEC 60601-1-2005, IEC 60601-1-2:2014, IEC 60601-1-11 Edition 2.0, and ISO 80601-2-61:2017; clinical accuracy studies per ISO 80601-2-61:2017 and FDA Pulse Oximeters Premarket Notification Guidance.

The proposed device is substantially equivalent because it has the same intended use (non-invasive spot-checking of SpO2 and pulse rate), identical fundamental design (transmittance optical sensor technology at the same wavelengths), same components and architecture, same sensor application site (finger), same power supply, same measurement parameters with comparable or superior accuracy (ARMS 1.70–1.71% versus predicate performance), and compliance with identical electrical safety standards (IEC 60601-1 and IEC 60601-1-11). Clinical studies demonstrated SpO2 accuracy performance meeting or exceeding predicate specifications.