510(k) K861436

SOF SET, MODELS 111 AND 112 by Pacesetter Systems — Product Code FRN

K861436 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "SOF SET, MODELS 111 AND 112". The FDA issued a decision of Substantially Equivalent on June 9, 1986. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Pacesetter Systems has at least 10 other 510(k) clearances on record.