DEVICE DETAILS
| NAME OF DEVICE | FINGERTIP PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | KENJO BABY HOUSE SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC9955125-194640 |
| BRAND NAME | EMASCARE |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | eMASCARE Fingertip Pulse Oximeter is composed of the main unit, power button and display screen OLED/TFT panel. The 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. The Pulse Oximeter use spectrophotometric principles. They transmit two wavelengths of light (660 and 905 nm) through a pulsating vascular bed on the nails and determine oxygen saturation using a variation of the Beer-Lambert law. The relationship between the absorption at the two wavelengths and oxygen saturation determines the calibration curve, which is derived empirically by each manufacturer. The pulse oximeter uses a microprocessor to calculate and display the SPO2 from the light absorption data. |
| DEVICE INTENDED PURPOSE | eMASCARE Fingertip 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 REGISTRATION | 18/01/2025 - 17/01/2030 |