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DEVICE DETAILS

NAME OF DEVICEFINGERTIP PULSE OXIMETER
ESTABLISHMENT NAMESMARTOPTZ PLT
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC10537221-68594
BRAND NAMEMBH
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe Fingertip Pulse Oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate.
DEVICE INTENDED PURPOSEThe Fingertip Pulse Oximeter is indicated for use in measuring oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for patients during no-motion condition. The patients are limited to adults and children (weight above 40kg or 88lb). The device is indicated for non-invasive spot checking.
VALIDITY DATE OF REGISTRATION07/08/2021 - 06/08/2026

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1FINGERTIP PULSE OXIMETERTD-8255
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