Covidien has announced that its Nellcor pulse oximetry portfolio received the US Food and Drug Administration (FDA) 510(k) clearance for motion claims.
The Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, includes the three devices, namely Nellcor Bedside SpO2 Patient Monitoring System, Nellcor Bedside Respiratory Patient Monitoring System and NellcorN-600 x Pulse Oximetry Monitoring System.
Pulse oximeters offer early warning of dangerous respiratory complications, enabling clinicians to detect and address life-threatening events sooner.
Covidien Respiratory and Monitoring Solutions president Robert White said, "The FDA’s recent clearance of motion-tolerance claims should now give clinicians added comfort that they’re providing the highest standard of patient care."
The 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 (SpO2) and pulse rate..
The devices 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.