510(k) K133870

FLUID LEVEL MONITOR by Coleman Laboratories — Product Code FLN

K133870 is an FDA 510(k) premarket notification submitted by Coleman Laboratories for the device "FLUID LEVEL MONITOR". The FDA issued a decision of Substantially Equivalent on April 24, 2014. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Coleman Laboratories has at least 1 other 510(k) clearance on record.