510(k) K855000

RATEMINDER III INFUSION DEVICE by American Edwards Laboratories — Product Code LDR

K855000 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "RATEMINDER III INFUSION DEVICE". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. American Edwards Laboratories has at least 10 other 510(k) clearances on record.