510(k) K896758

GAMBRO BICARBONATE MONITOR BCM 10-3 by Gambro, Inc. — Product Code FKP

K896758 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO BICARBONATE MONITOR BCM 10-3". The FDA issued a decision of Substantially Equivalent on September 28, 1990. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has at least 10 other 510(k) clearances on record.