DEVICE DETAILS
| NAME OF DEVICE | PULSE OXIMETER SAT 805 |
|---|---|
| ESTABLISHMENT NAME | AL GLOBAL CORPORATION (M) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC762641231018 |
| BRAND NAME | BITMOS |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | PULSE OXIMETRY IS A NONINVASIVE AND PAINLESS TEST THAT MEASURES YOUR OXYGEN SATURATION LEVEL, OR THE OXYGEN LEVELS IN YOUR BLOOD. IT CAN RAPIDLY DETECT EVEN SMALL CHANGES IN HOW EFFICIENTLY OXYGEN IS BEING CARRIED TO THE EXTREMITIES FURTHEST FROM THE HEART, INCLUDING THE LEGS AND THE ARMS. THE PULSE OXIMETER IS A SMALL, CLIP-LIKE DEVICE THAT ATTACHES TO A BODY PART, LIKE TOES OR AN EARLOBE. IT´S MOST COMMONLY PUT ON A FINGER, AND IT´S OFTEN USED IN A CRITICAL CARE SETTING LIKE EMERGENCY ROOMS OR HOSPITALS. SOME DOCTORS, SUCH AS PULMONOLOGISTS, MAY USE IT IN OFFICE |
| DEVICE INTENDED PURPOSE | THE DEVICE IS SUITABLE FOR ADULTS, CHILDREN AND NEWBORNS. SUITABILITY IS DUE TO THE AVAILABLE SENSORS THAT ALLOW MONITORING. FOR THIS PURPOSE, A DISTINCTION BASED ON WEIGHT CLASSES AND APPLICATION SITES IS FORMED |
| VALIDITY DATE OF REGISTRATION | 20/12/2018 - 19/12/2023 |