Covidien (COV) said it obtained 510(k) clearance from the U.S. Food and Drug Administration, or FDA, to market the Nellcor Bedside SpO2 Patient Monitoring System. Currently, the new patient monitoring system is available for sale in the U.S.
The Nellcor Bedside SpO2 system with OxiMax technology continuously monitors SpO2 and pulse rate for adult, pediatric and neonatal patients, thereby giving clinicians instant access to comprehensive trending respiratory information, and helps in detecting subtle, yet critical, heart rate and SpO2 variations earlier and thus address respiratory complications sooner.
Moreover, the Nellcor Bedside SpO2 Patient MonitoringSystem features an enhanced digital signal processing for precise SpO2 readings during low perfusion, while its SatSeconds alarm management technology differentiates between serious and minor events to reduce clinically insignificant oxygen desaturation alarms.
The Nellcor Bedside SpO2 Patient Monitoring System meets medical electrical equipment safety standards, including IEC 60601-1:2005, complying with the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment directive for products sold in European Economic Area markets.
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