510(k) K874137

MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR by Ash Medical Systems, Inc. — Product Code FKT

K874137 is an FDA 510(k) premarket notification submitted by Ash Medical Systems, Inc. for the device "MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR". The FDA issued a decision of Substantially Equivalent on April 8, 1988. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Ash Medical Systems, Inc. has at least 2 other 510(k) clearances on record.