NAME OF DEVICE	FINGERTIP PULSE OXIMETER
ESTABLISHMENT NAME	NORTHERNPLAS HEALTHCARE SDN BHD
ROLE OF ESTABLISHMENT	AUTHORIZED REPRESENTATIVE
REGISTRATION NO	GC3908622-86377
BRAND NAME	KONSUNG
MEDICAL DEVICE CATEGORY	MD 0104 - Non-active medical devices with measuring function
DEVICE GROUPING TYPE	FAMILY
DEVICE DESCRIPTION	Pulse oximeter is a noninvasive method for monitoring a person's oxygen saturation (SO2). Though its reading of SpO2 (peripheral oxygen saturation) is not always identical to the more desirable reading of SaO2 (arterial oxygen saturation) from arterial blood gas analysis, the two are correlated well enough that the safe, convenient, noninvasive, inexpensive pulse oximetry method is valuable for measuring oxygen saturation in clinical use. The fingertip pulse oximeter features in small volume, low power consumption, convenient operation and being portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show measured value of hemoglobin saturation. It has been proved in clinical experiments that it features in rather high precise and repeatability.
DEVICE INTENDED PURPOSE	to assess the safety of physical activity in people with cardiovascular or respiratory problems, or may recommend that a person wears a pulse oximeter while exercising.
VALIDITY DATE OF REGISTRATION	05/01/2022 - 04/01/2027