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DEVICE DETAILS

NAME OF DEVICECHECKME O2 PULSE OXIMETER
ESTABLISHMENT NAMEBMEC (MALAYSIA) SDN. BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB3693921-57628
BRAND NAMEOXIBAND
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONThe CheckMe O2 Pulse Oximeter measures the oxygen saturation and pulse rate. It works by shining two beams into the small blood vessels or capillaries of finger, reflecting the amount of oxygen in the blood and displaying the measurement.
DEVICE INTENDED PURPOSEThe Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. The Oxiband it is intended for spot-check and/ or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
VALIDITY DATE OF REGISTRATION10/03/2021 - 09/03/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Pulse OximeterOxiband
2SpO2 Ring SensorFP10R
3USB Charging Cable540-00240-00
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