DEVICE DETAILS
| NAME OF DEVICE | FINGERTIP OXIMETER |
|---|---|
| ESTABLISHMENT NAME | KSF MEDICARE (MALAYSIA) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB5291023-130926 |
| BRAND NAME | CREATIVE MEDICAL |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | This Fingertip Oximeter is applicable for spot-checking SpO2 and pulse rate of adult and pediatric patients in homes and medical clinics. Models with external sensor options and over-limit Indication may be used for longer periods of time dependent on the suitability of the sensor selected. |
| DEVICE INTENDED PURPOSE | This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through a patient’s finger. It is applicable for spot-checking SpO2 and pulse rate of adult and pediatric patients in homes and medical clinics. Models with external sensor options and over-limit Indication may be used for longer periods of time dependent on the suitability of the sensor selected. |
| VALIDITY DATE OF REGISTRATION | 15/05/2023 - 14/05/2028 |