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Covidien PLC Receives FDA 510(k) Clearance For Nellcor Pulse Oximetry Motion Claims


Monday, 20 May 2013 08:00am EDT 

Covidien PLC announced that its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for motion claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with ISO 80601-2-61 (International Organization for Standardization standards for pulse oximetry).