510(k) K080845

ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM by Cardinalhealth — Product Code JCX

K080845 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 30, 2008. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Cardinalhealth has at least 10 other 510(k) clearances on record.