510(k) K771478

INFUSION PUMP #6202 by Roche Medical Electronics, Inc. — Product Code FRN

K771478 is an FDA 510(k) premarket notification submitted by Roche Medical Electronics, Inc. for the device "INFUSION PUMP #6202". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Roche Medical Electronics, Inc. has at least 10 other 510(k) clearances on record.