510(k) K954501

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM by Medtronic Bio-Medicus, Inc. — Product Code DTY

K954501 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 1996. The device falls under product code DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4410. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.