510(k) K936091

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER by Medtronic Bio-Medicus, Inc. — Product Code DWA

K936091 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER". The FDA issued a decision of Substantially Equivalent on December 23, 1994. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.