510(k) K941922

MEDSAT OXYGEN SATURATION SYSTEM by Medtronic Bio-Medicus, Inc. — Product Code DRY

K941922 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "MEDSAT OXYGEN SATURATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 1995. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.