DEVICE DETAILS
NAME OF DEVICE | PULSE OXIMETER |
---|---|
ESTABLISHMENT NAME | ALLIANCE INTEGRITY TRADING SDN BHD |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GC4857822-85532 |
BRAND NAME | AEON TECHNOLOGY |
MEDICAL DEVICE CATEGORY | MD 1301 - Monitoring devices of non-vital physiological parameters |
DEVICE GROUPING TYPE | SINGLE |
DEVICE DESCRIPTION | A310L Pulse Oximeter is a non-invasive portable device intended for measuring functional oxygen saturation of arterial haemoglobin (SpO2) and pulse rate (PR) through finger. It is indicated to be used by adult and children at home as well as in clinical institutions. A310L Pulse Oximeter is a reusable device and is non-sterile. It is lightweight, small in size, low power consumption, convenient operation and portability. It only required patient to place one finger into fingertip photoelectric sensor for diagnosis, and the display screen will directly show measured value of functional oxygen saturation and pulse rate. |
DEVICE INTENDED PURPOSE | A310L Pulse Oximeter is a non-invasive portable device intended for measuring functional oxygen saturation of arterial haemoglobin (SpO2) and pulse rate (PR) through finger. It is indicated to be used by adult and children at home as well as in clinical institutions. |
VALIDITY DATE OF REGISTRATION | 11/02/2022 - 10/02/2027 |