510(k) K051209

LEVITRONIX CENTRIMAG BACK-UP CONSOLE by Levitronix, LLC — Product Code KFM

K051209 is an FDA 510(k) premarket notification submitted by Levitronix, LLC for the device "LEVITRONIX CENTRIMAG BACK-UP CONSOLE". The FDA issued a decision of Substantially Equivalent on September 8, 2005. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Levitronix, LLC has at least 10 other 510(k) clearances on record.