Covidien meldt FDA 510(k) toestemming voor Nellcor Respiration Rate Software

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Covidien meldt FDA 510(k) toestemming voor Nellcor Respiration Rate Software

Covidien meldt FDA 510(k) toestemming voor Nellcor Respiration Rate Software

^{Published on 2012-03-20 08:51:39 - Market Wire}

BOULDER, Colo.--([ BUSINESS WIRE ])--Covidien(NYSE: COV), leverancier van gezondheidsproducten en innovator in patintmonitoring en ademhalingsapparatuur, meldt dat de U.S. Food and Drug Administration (FDA) de 510(k) toestemming heeft gegeven aan het bedrijf om de Covidien Nellcor Respiration Rate Version 1.0 software en de Adult Respiratory Sensor op de markt te zetten. In 2011 heeft Covidien zijn ademhalingsmonitoring met het CE Mark gelabeld en het op de markt in Europa gezet. Het bedrijf plant een gelimiteerde productafzet op de Amerikaanse markt de komende maand.***

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal welke als enige juridische geldigheid beoogt.