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Covidien PLC's Nellcor Pulse Oximeters Receive FDA 510(k) Clearance With Labeling For Use In Newborn Screening For Critical Congenital Heart Disease


Tuesday, 28 May 2013 08:00am EDT 

Covidien PLC announced that its Nellcor pulse oximetry portfolio facilitates quick, noninvasive screenings for CCHD are U.S. Food and Drug Administration (FDA)-510(k) cleared for use on neonates, so physicians can rely on them for accurate CCHD screenings. As part of a broad effort to educate clinicians on the importance of CCHD screenings and encourage hospitals to implement routine CCHD screening for all newborns Covidien has begun labeling and promoting the use of Nellcor pulse oximetry as a tool to aid healthcare practitioners in CCHD screening.