510(k) K050107

HARVARD 2 SYRINGE PUMP, MODEL 2001-001 by Harvard Clinical Technology — Product Code FRN

K050107 is an FDA 510(k) premarket notification submitted by Harvard Clinical Technology for the device "HARVARD 2 SYRINGE PUMP, MODEL 2001-001". The FDA issued a decision of Substantially Equivalent on February 11, 2005. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Harvard Clinical Technology has at least 1 other 510(k) clearance on record.