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GE HEALTHCARE PTE. LTD.
Class C medical device
The Solar SPO2 Module and Solar Module with Masimo SET are intended for use under the direct supervision of a qualified practitioner. They are intended for continuous noninvasive monioring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Solar SPO2 Module and Solar Module with Masimo SET and accessories are intended for use with adult, pediatric and neonatal patirents in hospitals, hospital-type facilities, mobile and home environments.
Models: Solar Pulse Oximetry Module - SLRSPO2MAS-AP=A, Solar Pulse Oximetry Module - SLRSPO2MAS-N=A, Solar SPO2 Module - SLRSPO2=A