510(k) K962320

S3 CARDIOPLEGIA CONTROL by Stoeckert Instrumente — Product Code DTR

K962320 is an FDA 510(k) premarket notification submitted by Stoeckert Instrumente for the device "S3 CARDIOPLEGIA CONTROL". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Stoeckert Instrumente has at least 10 other 510(k) clearances on record.