510(k) K120823

BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS by Fresenius Medical Care North America, Design Cente — Product Code FJK

K120823 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America, Design Cente for the device "BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS". The FDA issued a decision of Substantially Equivalent on June 15, 2012. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care North America, Design Cente has at least 4 other 510(k) clearances on record.