Portfolio of Nellcor Pulse Oximeters Receive FDA 510(k) Clearance

The Nellcor pulse oximetry portfolio—including the NellcorTM Bedside SpO2 Patient Monitoring System, NellcorTM Bedside Respiratory Patient Monitoring System, and NellcorTM N-600x Pulse Oximetry Monitoring System—received FDA 510(k) clearance for Critical Congenital Heart Disease screenings on neonates. Nellcor pulse oximeters, manufactured by Covidien, are the first and only oximeters to comply with ISO 80601-2-61 International Organization for Standardization.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Congenital Heart Disease

Keywords: Heart Defects, Congenital, Infant, Newborn, Monitoring, Physiologic, Oximetry


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