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DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER
ESTABLISHMENT NAMEIHB HEALTHCARE SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB2871326-234274
BRAND NAMEAEON
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONAeon Pulse Oximeter is based on digital technology. The device is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP algorithm can minimize the influence of motion artifact and improve measurement accuracy of low perfusion. Pulse Oximeter can be used to measure human SpO2 and pulse rate through the finger. The product is suitable for private home-use, hospitals (including clinical use in internist/surgery, anesthesia, pediatrics etc.), social medical organizations, physical care in sports etc.
DEVICE INTENDED PURPOSEAeon Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is suitable for non-professional adult patients of any color in clinical institutions and home environments.
VALIDITY DATE OF REGISTRATION18/06/2026 - 17/06/2031

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