About This 510(k) Submission
K120017 is an FDA 510(k) clearance for the FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on February 2, 2012, 30 days after receiving the submission on January 3, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.