Opto Circuits (India) has received Section 510(K) US FDA  approval on two of its new generation range of Pulse Oximeters. The  certification enables OCI to market its M30 and M34 Models of Pulse Oximeters in the United States which is the largest market for these products.

 

Opto Circuits (India) Ltd. (OCI), India’s leading manufacturer of medical diagnostics and interventional products, today received Section 510(K) US FDA (United States Food & Drug Administration) approval on two of its new generation range of Pulse Oximeters. The latest certification enables OCI to market its M30 and M34 Models of Pulse Oximeters in the United States which is the largest market for these products. A Pulse oximeter is a non-invasive diagnostic device for detecting the pulse rate and percentage of hemoglobin (Hb) that is saturated with arterial oxygen.

Mediaid, the 100 per cent subsidiary of OCI, will begin marketing the product within the US. The global market size for pulse oximeters is estimated to be around US$800mn. The M30 and M34 Models are already being successfully marketed in European and Asian countries.