510(k) K150513

Imed Technology Intravascular Administration Set, Imed Technology Extension Set by Imed Technology, Inc. — Product Code FPA

K150513 is an FDA 510(k) premarket notification submitted by Imed Technology, Inc. for the device "Imed Technology Intravascular Administration Set, Imed Technology Extension Set". The FDA issued a decision of Substantially Equivalent on May 28, 2015. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Imed Technology, Inc. has 1 other 510(k) clearance on record.