DEVICE DETAILS
| NAME OF DEVICE | HANDHELD PULSE OXIMETER (SP-20) |
|---|---|
| ESTABLISHMENT NAME | LEPU COMMERCE(MALAYSIA) SDN.BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC4638724-178881 |
| BRAND NAME | LEPU MEDICAL |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | This Handheld Pulse Oximeter is intended for measuring and recording the pulse rate,functional oxygen saturation (SpO2), and temperature (optional). It is applicable for detecting SpO2, pulse rate, and temperature of adult and neonate patients in clinical institutions and homes. ● It is applicable for adults, paediatric, and neonate measurements in hospital and home. ● Measuring Sp02, Pulse Rate and Temperature (optional) ● 3.5-inch TFT display of PI%, plethysmograph and pulse bar ● 16 user IDs for marking data and can be added ● A built-on holder for convenient standing on desktop ● The base is used to hold the oximeter, and also for charging. ● Lithium battery up to 18 hours ● More than 500 hours Sp02 and PR data storage ● PC software for data management. ● Audible and visual alert function is available ● Auto power off is available |
| DEVICE INTENDED PURPOSE | This Handheld Pulse Oximeter is intended for measuring and recording the pulse rate, functional oxygen saturation (SpO2), and temperature (optional). It is applicable for detecting SpO2, pulse rate, and temperature of adult and neonate patients in clinical institutions and homes. |
| VALIDITY DATE OF REGISTRATION | 08/08/2024 - 07/08/2029 |