DEVICE DETAILS
NAME OF DEVICE | PULSE OXIMETER |
---|---|
ESTABLISHMENT NAME | PERNIAGAAN BEKALAN ABADI SDN BHD |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GB9253021-66450 |
BRAND NAME | LITEXIM |
MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and testes in home This device is not intended for continuous monitoring. The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, socalled the OZ concentration in the blood. It is an important bic-parameter for the respiration. For the purpose of measuring the SpO2 more and accurately, our company developed the Pulse Oximeter. At the same time, the device can measure the pulse rate simultaneously. The Pulse Oximeter features in small volume, low power consumption, convenient operation and being portable. It is only necessary for testes to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show measured value of Hemoglobin Saturation. |
DEVICE INTENDED PURPOSE | The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and testes in home This device is not intended for continuous monitoring |
VALIDITY DATE OF REGISTRATION | 21/06/2021 - 20/06/2026 |