DEVICE DETAILS
NAME OF DEVICE | PULSE OXIMETER |
---|---|
ESTABLISHMENT NAME | CYPRESS MEDIC SDN BHD |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GC6493119-36113 |
BRAND NAME | ROSSMAX |
MEDICAL DEVICE CATEGORY | MD 1300 - MONITORING DEVICES |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | Rossmax Pulse Oximeter is used to measure arterial oxygen saturation(%SpO2) of hemoglobin and pulse rate, an important indicator of respiratory function. The model of fingertip pulse oximeter, only for SB200 and SB210, have an ACT analysis function. ACT (Artery Check Technology) analyzes the pulse and SpO2 signals and determines the actually prevailing stiffness of the artery (Artery Condition). If further classifies the vascular status into 6 level |
DEVICE INTENDED PURPOSE | SB Series: Rossmax Fingertip Pulse Oximeter is used to measure arterial oxygen saturation (% SpO2) of hemoglobin and pulse rate, an important indicator of your respiratory function. The model of fingertip pulse oximeter, only for SB200 and SB210, have an ACT (Artery Check Technology) analysis function that analyzes the pulse and SpO2 signals and determines the actually prevailing stiffness of the artery (Artery Condition). It is non-invasive device intended for spot -check of adult and pediatric whose age is over 3 at home, hospital. |
VALIDITY DATE OF REGISTRATION | 22/10/2024 - 21/10/2029 |