DEVICE DETAILS
| NAME OF DEVICE | PULSE OXIMETER SAT 801DELTA |
|---|---|
| ESTABLISHMENT NAME | AL GLOBAL CORPORATION (M) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC575171246719 |
| BRAND NAME | BITMOS |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | PULSE OXIMETER IS A MEDICAL DEVICES THAT MONITOR THE LEVEL OF OXYGEN IN A PATIENT'S BLOOD AND ALERT THE HEALTH-CARE WORKER IF OXYGEN LEVELS DROP BELOW SAFE LEVELS,ALLOWING RAPID INTERVENTION. THESE DEVICES ARE ESSENTIAL IN ANY SETTING IN WHICH A PATIENT'S BLOOD OXYGEN LEVELS REQUIRES MONITORING LIKE OPERATIONS, EMERGENCY AND INTENSIVE CARE, AND TREATMENT AND RECOVERY IN HOSPITAL WARD |
| DEVICE INTENDED PURPOSE | THE OXIMETER IS INTENDED FOR CONTINUOUS MONITORING OR SPOT-CHECKING OF FUNCTIONAL ARTERIAL OXYGEN SATURATION (SPO2) AND PULSE RATE OF ADULT, PEDIATRIC OR NEONATAL PATIENTS IN HOSPITALS, INTRA-HOSPITAL TRANSPORT AND HOSPITAL GRADE FACILITIES. |
| VALIDITY DATE OF REGISTRATION | 28/12/2018 - 27/12/2023 |