DEVICE DETAILS
| NAME OF DEVICE | PULSE OXIMETER OLV-2700K |
|---|---|
| ESTABLISHMENT NAME | NIHON KOHDEN MALAYSIA SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC14352301217 |
| BRAND NAME | NIHON KOHDEN (OLV-2700K) |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | THE OLV-2700K PULSE OXIMETER IS A PORTABLE INDOOR-USE MONITOR THAT MEASURES SPO2 OF A PATIENT IN THE HOSPITAL. THIS PULSE OXIMETER DISPLAYS THE PATIENT’S SPO2 AND PULSE RATE, AND GENERATES ALARMS. YOU CAN RUN IT ON AC OR BATTERY POWER ACCORDING TO THE LOCATION, SUCH AS ER, OPERATION ROOM, ICU, GENERAL WARD, ETC. THE PULSE OXIMETER IS DESIGNED SO THE OPERATOR CAN DIRECTLY PRESS THE KEYS FROM THE OPERATOR POSITION. THE LED DISPLAY SHOWS SPO2 VALUE AND PULSE RATE. |
| DEVICE INTENDED PURPOSE | THIS DEVICE MONITORS THE RESPIRATORY CONDITION OF A PATIENT BY MEASURING THE ARTERIAL OXYGEN SATURATION (SPO2) AND PULSE RATE (PR) IN A CONTINUOUS NON-INVASIVE MANNER. THE WAVEFORM SIGNALS CORRESPONDING TO THE VALUES MEASURED BY THIS DEVICE CAN BE ALSO OUTPUT BY CONNECTING TO A NIHON KOHDEN VITAL INFORMATION MONITOR VIA MONITOR INTERFACE KIT. |
| VALIDITY DATE OF REGISTRATION | 25/08/2017 - 24/08/2022 |