Covidien Announces FDA 510(k) Clearance of Nellcor Respiration Rate Software
Covidien (NYSE: COV) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Company to market the Covidien Nellcor™ Respiration Rate Version 1.0 software and the Adult Respiratory Sensor.
In late 2011, Covidien labeled the respiratory monitoring platform with the CE Mark and began to market it throughout the European Economic Area. The Company plans a limited market release in the U.S., starting next month, which will allow select hospitals to be the first to use the new technology.
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