DEVICE DETAILS
| NAME OF DEVICE | PULSE OXIMETER PROBE REUSABLE / PULSE OXIMETER PROBE |
|---|---|
| ESTABLISHMENT NAME | AL GLOBAL CORPORATION (M) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC154311365819 |
| BRAND NAME | MED-LINKET |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | THE REUSABLE SPO2 SENSOR USES TWO EMITTING LED'S ONE IN THE RED REGION AND THE OTHER IN THE INFRARED REGION OF THE SPECTRUM. THE REFLECTED LIGHT OF EACH ONE OF THESE LED'S IS ABSORBED BY A PHOTODIODE THAT CONVERTS THIS CURRENT INTO A DIGITAL VALUE THAT IS SENT VIA SPI .THIS SENSOR CAN BE USED TO ESTIMATE THE OXYGEN SATURATION LEVEL. |
| DEVICE INTENDED PURPOSE | SHENZHEN MED-LINK PULSE OXIMETER PROBES ARE INDICATED FOR COLLECTION AND TRANSFERS THE SIGNALS OF PULSE AND OXYGEN FROM THE PATIENT BODY TO OXIMETER. THE DEVICE APPLICATION SITES FOR TESTING INCLUDING FOOT, HAND, FINGER AND TOE WHEN APPLY APPROPRIATE SENSOR MODES. THE SENSOR COMES IN 8 DIFFERENT TYPES OF SENSOR WHICH ARE:- 1.ADULT FINGER CLIP SPO2 SENSOR SERIES, FOR ADULT >40KG 2.PEDIATRIC FINGER CLIP SPO2 SENSOR SERIES, FOR PEDIATRIC>10-40KG 3.ADULT SILICONE SPO2 SENSOR SERIES,FOR ADULT >40KG 4.PEDIATRIC(MEDIUM SIZE) SILICONE SPO2 SENSOR, FOR PATIENTS FINGER THICKNESS 7-12 MM(PEDIATRIC 10-40KG) 5.INFANT SILICONE SPO2 SENSOR SERIES, FOR INFANT 4-15KG 6.NEONATE SILICONE WRAP SPO2 SENSOR,FOR NEONATE 1-4KG 7.Y TYPE MULTISITE SENSOR SERIES,FOR ADULT>40KG 8.ADULT EAR CLIP SPO2 SENSOR SERIES,FOR ADULT>40KG |
| VALIDITY DATE OF REGISTRATION | 04/12/2019 - 03/12/2024 |