510(k) K863609

SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 by International Medical Products, Inc. — Product Code FKP

K863609 is an FDA 510(k) premarket notification submitted by International Medical Products, Inc. for the device "SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22". The FDA issued a decision of Substantially Equivalent on February 25, 1987. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. International Medical Products, Inc. has at least 9 other 510(k) clearances on record.