510(k) K871218

MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT by Hospal Medical Corp. — Product Code FKP

K871218 is an FDA 510(k) premarket notification submitted by Hospal Medical Corp. for the device "MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT". The FDA issued a decision of Substantially Equivalent on April 30, 1987. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Hospal Medical Corp. has at least 10 other 510(k) clearances on record.