Covidien’ s oximeter gets US FDA approval

Covidien’s new device Nellcor Portable SpO2 Patient Monitoring System has been approved by the US regulatory body

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The device is a part of the company's respiratory function monitoring portfolio

Covidien has announced that the Food and Drug Administration has given it 510(k) clearance for the Nellcor Portable SpO2 Patient Monitoring System (PM10N). This portable oximeter is equipped with home care and sleep study modes and complies with IEC 60601-1-11 standards for devices used in the home health care environment.

The device is a part of the company's respiratory function monitoring portfolio, this convenient, handheld patient monitor is user-friendly and ideal for fast, accurate, motion-tolerant monitoring of pulse rate and blood oxygenation (SpO2). The Nellcor Portable SpO2 Patient Monitoring System's compact design and ability to perform in challenging conditions make it an ideal tool for multiple critical clinical screenings.

"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," said Mr Matt Anderson, vice president and general manager, patient monitoring, Covidien. He added, "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."

 

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