DEVICE DETAILS
NAME OF DEVICE | FINGERTIP PULSE OXIMETER |
---|---|
ESTABLISHMENT NAME | REVO HEALTHCARE SDN BHD |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GC2160119-29755 |
BRAND NAME | CHOICEMMED |
MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | The Fingertip Pulse Oximeter is a portable non invasive device used to measure and record the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of users at any moment. It is a small and compact device which is applicable in the hospital and home use with simple and convenient operation. However, it is reminded that the Fingertip Pulse Oximeter is not suitable for continuous blood oxygen monitoring. The measuring range for the SpO2 is 70% to 100% with 1% resolution while the measuring range for the pulse rate is 30 to 250 beats per minute (bpm) with a resolution of 1 bpm. |
DEVICE INTENDED PURPOSE | The Fingertip Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital type facilities and homecare. It is not for continuous monitoring. |
VALIDITY DATE OF REGISTRATION | 12/06/2024 - 11/06/2029 |