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DEVICE DETAILS

NAME OF DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMEREANNEQ SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGC6815326-240546
BRAND NAMEOUSON+
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe Fingertip Pulse Oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of hemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery.
DEVICE INTENDED PURPOSEThe fingertip pulse oximeter is a non-invasive device intended for measure oxygen saturation (SpO2) and pulse rate of adults or children.
VALIDITY DATE OF REGISTRATION20/08/2026 - 19/08/2031

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