DEVICE DETAILS
| NAME OF DEVICE | PULSE OXIMETER OLV-4201 |
|---|---|
| ESTABLISHMENT NAME | NIHON KOHDEN MALAYSIA SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC95939699418 |
| BRAND NAME | NIHON KOHDEN (OLV-4201) |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | THE PULSE OXIMETER IS A COMPACT MONITOR WITH A 7-INCH DISPLAY AND IS DESIGNED FOR TOUCHSCREEN OPERATION AT THE PATIENT’S SIDE. THE PULSE OXIMETER IS INSTALLED NEAR THE PATIENT TO DISPLAY THE PATIENT’S VITAL SIGNS (SPO2, PULSE RATE, ETC.) ON THE DISPLAY AND GENERATE ALARMS. NEONATES, CHILDREN AND ADULTS CAN BE MONITORED WITH THIS PULSE OXIMETER. WHEN THE OPERATION MODE IS SET TO NETWORK MODE, THE PULSE OXIMETER CAN CONNECT TO A NIHON KOHDEN CENTRAL MONITOR NETWORK AND COMMUNICATE WITH CENTRAL MONITORS AND BEDSIDE MONITORS IN THE NETWORK. |
| DEVICE INTENDED PURPOSE | THE PULSE OXIMETER IS INSTALLED NEAR THE PATIENT TO DISPLAY THE PATIENT’S VITAL SIGNS (SPO2, PULSE RATE, ETC.) ON THE DISPLAY AND GENERATE ALARMS. THIS PULSE OXIMETER MUST BE USED BY QUALIFIED MEDICAL PERSONNEL WITH FULL KNOWLEDGE OF ITS FUNCTIONS AND OPERATIONS WITHIN THE ENVIRONMENT OF HOSPITALS SUCH AS CRITICAL CARE, ICU, HCU, OR, GCU, OUTPATIENT CLINIC, GENERAL WARD AND SO ON. IT IS NOT INTENDED FOR PATIENTS TO USE. IT IS NOT INTENDED TO USE OUTSIDE OR AT HOME, EITHER. |
| VALIDITY DATE OF REGISTRATION | 22/02/2023 - 21/02/2028 |