Trade Resources Industry Views FDA Has Granted Clearance to Covidien's Nellcor Bedside SpO2 Patient Monitoring System

FDA Has Granted Clearance to Covidien's Nellcor Bedside SpO2 Patient Monitoring System

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Covidien's Nellcor bedside SpO2 patient monitoring system.

The Nellcor bedside SpO2 monitor, which utilizes OxiMax technology, is designed for detecting heart rate and oxygen saturation (SpO2) variations earlier and address respiratory complications sooner.

The system features an intuitive, multicolor screen to note the reading in any light and from many angles and SatSeconds alarm management technology to differentiate serious and minor events to reduce clinically insignificant oxygen desaturation alarms.

The Nellcor bedside SpO2 system continuously monitors SpO2 and pulse rate of adult, pediatric and neonatal patients and facilitates clinicians instant access to comprehensive trending respiratory information.

During low perfusion or other challenging conditions, the Nellcor bedside SpO2 monitor uses digital signal processing to read SpO2 levels and to track the patients.

The company said hospital technicians can set institutional defaults, replace the battery, perform diagnostics and maintain the monitor within the hospital to save time and resources.

Covidien respiratory and monitoring solutions president Robert White healthcare professionals on the general care floor, and in other lower- acuity areas of the hospital, need critical patient information at their fingertips so they can respond quickly to health threats.

"By giving them ready access to a patient's respiratory history, the system allows them to focus on delivering efficient, high-quality care, not gathering and managing data," White added.

Source: http://patientmonitoring.medicaldevices-business-review.com/news/covidien-nellcor-bedside-spo2-monitor-wins-fda-nod-310712
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Covidien Nellcor Bedside SpO2 Monitor Wins Fda Nod