Fenwal Receives 60601-1 3rd Edition Certification for Aurora Plasmapheresis System
7/25/2013 9:57:24 AM
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LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fenwal, a Fresenius Kabi company, announced today it has received 60601-1 3rd edition certification for the Aurora™ plasmapheresis system designed for collection of plasma. 60601-1 3rd edition is the latest international consensus standard representing the current “state of the art” for medical device design and allows Fenwal to market the Aurora system in Europe. Aurora, which received U.S. FDA 510(k) clearance in April 2012, represents the latest Fenwal advancement in plasma collection technology.
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