Covidien (COV: Quote) announced that its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received FDA 510(k) clearance for motion claims. Covidien said it is the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with ISO 80601-2-61.
The devices covered by the action: Nellcor Bedside SpO2 Patient Monitoring System; Bedside Respiratory Patient Monitoring System; and N-600x Pulse Oximetry Monitoring System are indicated for prescription-use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate. They are intended for neonatal, pediatric, and adult patients, and for well or poorly perfused patients in hospitals, hospital-type facilities, intra-hospital transport and home environments.
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by RTT Staff Writer
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