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DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER
ESTABLISHMENT NAMEAA ALIVE SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGB10889026-231055
BRAND NAMEIMDK
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR). The device measures SpO2 and PR with a SpO2 senor and displays on the display screen after certain further processing, it can be used to measure human Hemoglobin Saturation and heart rate through finger.
DEVICE INTENDED PURPOSEThe Pulse Oximeter is a portable non-invasive device intended for use in measuring and displaying oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adults through the finger in hospitals, hospital-type facilities, and home environments. The patient is an intended operator
VALIDITY DATE OF REGISTRATION16/04/2026 - 15/04/2031

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