Covidien secures FDA 510(k) approval for Nellcor Portable SpO2 patient monitoring system

12 October 2014 (Last Updated October 12th, 2014 18:30)

Covidien has secured US Food and Drug Administration (FDA) 510(k) clearance for the Nellcor Portable SpO2 Patient Monitoring System (PM10N).

Covidien has secured US Food and Drug Administration (FDA) 510(k) clearance for the Nellcor Portable SpO2 Patient Monitoring System (PM10N).

The system is equipped with a 3in colour LCD screen and is compatible with all Nellcor sensors with OxiMax technology.

Used for accurately measuring pulse rate and blood oxygenation (SpO2), the device is compact and works well in challenging conditions. This makes it suitable for multiple critical clinical screenings including the six minute walk test, critical congenital heart disease screening and the car seat challenge test.

The PM10N has different modes including home care and sleep study, where the utility transforms the monitor and controls to adjust to the selected mode.

"The development of this product exemplifies Covidien's dedication to enhance patient care, both inside and beyond the hospital."

It is lightweight, user-friendly and complies with IEC 60601-1-11 standards for devices used in the home health care environment.

Covidien's patient monitoring vice-president and general manager Matt Anderson said: "Covidien's new generation of portable monitors is easy-to-use and brings our proven pulse oximetry technology to patients inside the hospital, in health care facilities, and even in their own homes.

"Because our pulse oximetry technology relies on cardiac signals, it mitigates signal interference, offering caregivers peace of mind.

"They can count on Covidien to provide accurate patient data, even during difficult conditions. The development of this product exemplifies Covidien's dedication to enhance patient care, both inside and beyond the hospital."