DEVICE DETAILS
| NAME OF DEVICE | FINGERTIP PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | WFR MEDICAL SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB7254223-147080 |
| BRAND NAME | WFR |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Fingertip pulse oximeter is a device that uses non-invasive method to measure the blood oxygen saturation and pulse rate. It is based on the principle of differential wavelength absorption.The oximeter is suitable for family, clinic, oxygen bar, sports health (use before and after exercise is not recommended for use during exercise), community health and other ranges. Oxygen saturation is an important physiological parameter that characterizes. The oxygen carrying capacity of blood. Many respiratory diseases can result in low oxygen saturation in human blood. Additionally, the following factors can reduce oxygen saturation: Automatic regulation of organ dysfunction caused by Anesthesia, Intensive Postoperative Trauma, injuries caused by some medical examinations. That situation might result in light-headedness, asthenia, vomiting and other symptoms, severe cases will be life-threatening. Therefore, it is very important to know the oxygen saturation of a patient so that doctors can find problems timely. |
| DEVICE INTENDED PURPOSE | The Fingertip Oximeter is intended to measure the pulse oxygen saturation of arterial hemoglobin and pulse rate of adults and pediatrics in home care and medical outpatient environment. |
| VALIDITY DATE OF REGISTRATION | 07/09/2023 - 06/09/2028 |