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DEVICE DETAILS

NAME OF DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMEFELCO MEDICAL SUPPLIES SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC2231721-73320
BRAND NAMEHEARTCARE
MEDICAL DEVICE CATEGORYMD 1300 - MONITORING DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe product is mainly indicated for measurement of human Oxygen Saturation (SpO2), Pulse Rate (PR) and PI (Perfusion Index). The product has visual prompts and verbal prompts (optional), such as finger out and pulse sound (optional). The applied part of this device is silicone sleeve. The measuring principles of pulse oximeter is based on Lambert-Beer law, the spectrum absorption characteristics is different of Reductive hemoglobin (RHb) and Oxyhemoglobin (Hbo2) in red light and near-infrared light zones. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) from this color difference by measuring the ratio of absorbed red and infrared light as volume fluctuates with each pulse.
DEVICE INTENDED PURPOSEFingertip pulse oximeter is intended for noninvasive measurement of oxygen saturation, pulse rate and perfusion index in homecare and hospitals, applicable for children and adult.
VALIDITY DATE OF REGISTRATION23/09/2021 - 22/09/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Fingertip Pulse OxymeterLOX100A
2Fingertip Pulse OxymeterLOX100B
3Fingertip Pulse OxymeterLOX100C
4Fingertip Pulse OxymeterLOX100D
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