510(k) K950990

STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE by Stoeckert Instrumente — Product Code DTQ

K950990 is an FDA 510(k) premarket notification submitted by Stoeckert Instrumente for the device "STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE". The FDA issued a decision of Substantially Equivalent on January 19, 1996. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Stoeckert Instrumente has at least 10 other 510(k) clearances on record.