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www.fdanews.com/articles/138408-edwards-lifesciences-receives-510-k-clearance-for-ev1000-clinical-monitoring-platform

Edwards Lifesciences Receives 510(k) Clearance for EV1000 Clinical Monitoring Platform

July 15, 2011
Edwards Lifesciences has been granted a 510(k) clearance from the FDA for its EV1000 clinical monitoring platform. The device uses a touch-screen monitor to display a patient’s physiologic status, and is designed to simplify decisionmaking in the operating room and intensive care unit.