510(k) K853134

NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 by Erika, Inc. — Product Code FRN

K853134 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8". The FDA issued a decision of Substantially Equivalent on November 6, 1985. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Erika, Inc. has at least 10 other 510(k) clearances on record.