Covidien Announces FDA 510(k) Clearance of the Nellcor Bedside SpO2 Patient Monitoring System

Covidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care solutions, has been granted 510(k) clearance to market the Covidien Nellcor Bedside SpO₂Patient Monitoring System by the U.S. Food and Drug Administration (FDA). The new patient monitoring system is now available for sale in the United States.

The Nellcor Bedside SpO₂ system with OxiMax technology continuously monitors SpO₂ and pulse rate for adult, pediatric and neonatal patients, giving clinicians instant access to comprehensive trending respiratory information. This enables clinicians to detect subtle, yet critical, heart rate and SpO₂ variations earlier and thus address respiratory complications sooner.

“We are pleased to announce the new Covidien Nellcor Bedside SpO₂ Patient Monitoring System is approved for commercial release in the United States,” said Robert J. White, president, Respiratory and Monitoring Solutions, Covidien. “Healthcare professionals on the general care floor, and in other lower-acuity areas of the hospital, need critical patient information at their fingertips so they can respond quickly to health threats. By giving them ready access to a patient’s respiratory history, the system allows them to focus on delivering efficient, high-quality care, not gathering and managing data.”

The Nellcor Bedside SpO₂ Patient Monitoring System also features enhanced digital signal processing for precise SpO₂readings during low perfusion or other challenging conditions that make it difficult to accurately track these patients. Its SatSeconds alarm management technology differentiates between serious and minor events to reduce clinically insignificant oxygen desaturation alarms. The monitor further offers an intuitive, multicolor screen that is easy to read in any light and from many angles. Additionally, hospital technicians can set institutional defaults, replace the battery, perform diagnostics and generally maintain the monitor within the hospital, saving time and resources.

The Nellcor Bedside SpO₂ Patient Monitoring System meets medical electrical equipment safety standards, including IEC 60601-1:2005, and complies with the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) directive for products sold in European Economic Area markets.

About Covidien
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. www.covidien.com