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Opto gets USFDA nod for pulse oximeters

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Announcement Corporate
Last Updated : Feb 05 2013 | 2:36 AM IST
Bangalore, 7th November 2007: 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.
 
 
About Model 30 Pulse Oximeter:
 
 
This is a handheld oximeter designed for convenience in spot checking and is ideal for the physician's office, hospitals & clinics, diagnostic centres and home health care. Model 30 has bright LED display visible in most lighting conditions and comes with bar graph displays for Pulse Amplitude & Perfusion Quality indication. The inbuilt rechargeable Lithium Ion Battery runs the oximeter for approx. 18 hours.
 
 
About Model 34 Pulse Oximeter:
 
 
This is a handheld oximeter ideal for most continuous monitoring applications. The salient features of Model 34 are Bright LED display, Bar Graph, Audio / Visual Alarms, Memory, Rechargeable Battery, USB & Infrared Ports and Printer option. Tags patient readings automatically with Patient number, the time and date of the reading, can store 136 hours of information for a single patient, making the device useful for treadmill and other long tests, can be used in walk around test, storing more than 7200 data for upto 20 consecutive patients, can be used for sleep screening where data can be stored every 5 seconds for upto to 18 hours. Enables data to be printed or transmitted to a computer via the Infrared Port or the USB Port. Performs approximately 24 hours of operation on a single rechargeable Lithium Ion battery, (sleep mode).
 
 
About Opto Circuits (India) Ltd.
 
 
Opto Circuits (India) Ltd. (OCI) (BSE Code: 532391; NSE Symbol: OPTOCIRCUI is a leading manufacturer of healthcare equipments in India. The product profile includes digital thermometers, sensors, probes, pulse oximeters, patient monitoring systems, Stents and Catheters. Other innovative products are in the pipeline. In 2001, OCI acquired 60 per cent stake in Advanced Micronic Devices to market its equipments in India. OEMs contribute (80per cent) of sales while MediAid (100per cent US-based subsidiary) contributes the balance. MediAid came into existence with the acquisition of the patient monitoring division of Palco Labs, US, in end-2003 and now markets OCI's products in the US markets directly. OCI acquired EuroCor Gmbh during 2006. EuroCor manufactures Cardiac Stents of various types, including Drug Eluting Coronary stents used in critical cardiac care. In April 2007, OCI ventured into new product segments - Urology, Gastroenterology, Gynecology and Orthopedics by acquiring Devon Innovations Private Limited (Bangalore) and Ormed Medical Technology Limited (Chennai). Visit us at www.optoindia.com.
 
 
 

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First Published: Nov 07 2007 | 12:00 AM IST

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