510(k) K102129

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR by Levitronix, LLC — Product Code DWA

K102129 is an FDA 510(k) premarket notification submitted by Levitronix, LLC for the device "LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Levitronix, LLC has at least 10 other 510(k) clearances on record.