510(k) K900815

SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL by 3M Company — Product Code DTW

K900815 is an FDA 510(k) premarket notification submitted by 3M Company for the device "SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL". The FDA issued a decision of Substantially Equivalent on May 9, 1990. The device falls under product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4340. 3M Company has at least 10 other 510(k) clearances on record.