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DEVICE DETAILS

NAME OF DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMESYMBIOMED SDN. BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC2456023-133310
BRAND NAMEALVITAL
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe Fingertip Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking in home and professional caring environment. The Fingertip Pulse Oximeter is as a stand-only device for multiple use with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings.
DEVICE INTENDED PURPOSEThe Fingertip Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0,3 inches ~0,9 inches) and for patients during no-motion condition.
VALIDITY DATE OF REGISTRATION29/05/2023 - 28/05/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Alvital Fingertip Pulse oximeterAT101B
2Alvital Fingertip Pulse oximeterAT101C
3Alvital Fingertip Pulse oximeter (Wireless)AT101I
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