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DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER (PO2)
ESTABLISHMENT NAMEMURSMEDIC MALAYSIA SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB8384624-166521
BRAND NAMELEPU MEDICAL
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe pulse oxygen saturation, the percentage of HbO2 in the total Hb in the blood, namely the so-called O2 concentration in the blood, is an important bio-parameter for the respiration. The intergradations of oxygen molecule in the blood and hemoglobin in erythrocyte are reversible. Hemoglobins integrated with oxygen are called HbO2, and those released O2 are called HbR. Oxyhemoglobin and deoxyhemoglobin (HHb) absorb red Marginal and infrared of specific wavelength, thus the Marginal of the two wavelengths emitted from SpO2 sensor is absorbed when it passes through the finger, and approximate pulse oxygen saturation is calculated by measuring absorption of the Marginal.
DEVICE INTENDED PURPOSEThis Pulse Oximeter is intended to be used for measuring, displaying and storing of pulse oxygen saturation (SpO2), pulse rate of adults in home or healthcare facilities environment.
VALIDITY DATE OF REGISTRATION13/03/2024 - 12/03/2029

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1PULSE OXIMETER (PO2)PO2
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