Covidien wins US Food and Drug Administration's 510(k) clearance for Nellcor Portable SpO2 Patient Monitoring System for home care settings.
M2 EQUITYBITES-October 10, 2014-Covidien wins US Food and Drug Administration's 510(k) clearance for Nellcor Portable SpO2 Patient Monitoring System for home care settings
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Healthcare company Covidien (NYSE:COV) disclosed on Thursday the receipt of approval from the US Food and Drug Administration 510(k) clearance for the Nellcor Portable SpO2 Patient Monitoring System (PM10N).
The company added that the PM10N system is the only commercially available portable oximeter that 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. It is simple to use and ideal for fast, accurate, motion-tolerant monitoring of pulse rate and blood oxygenation (SpO2).
This Nellcor Portable SpO2 Patient Monitoring System's compact design and ability to perform in challenging conditions makes it an ideal tool for multiple critical clinical screenings including Six Minute Walk Test, Critical Congenital Heart Disease Screening and Car Seat Challenge Test, said the company.
According to the company, the monitoring system includes a vivid three-inch color LCD screen, connectivity to analytics tools and patient management systems, compatible with Nellcor sensors with OxiMax technology and offers SpO2, pulse rate, SatSeconds alarm management, pleth waveform, blip bar and tabular trend information.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Oct 10, 2014|
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