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According to CDSCO guidelines, Respiratory oxygen therapy monitor/regulator falls under Risk Class B under Anesthesia category of Medical Devices. Intended use - An electrically-powered unit designed to be connected to a pulse oximeter sensor and used during the administration of oxygen (O2) to a spontaneously breathing patient, for: 1) continuous monitoring of physiologic parameters, especially haemoglobin oxygen saturation (SpO2); and 2) dynamic regulation of the amount of O2 delivered to the patient based on physiological parameter measurements.. This article will give you complete information about manufacturing Respiratory oxygen therapy monitor/regulator