510(k) K140131

SUB-Q SUBCUTANEOUS TISSUE INFUSION SET by Emed Technologies Corporation — Product Code FPA

K140131 is an FDA 510(k) premarket notification submitted by Emed Technologies Corporation for the device "SUB-Q SUBCUTANEOUS TISSUE INFUSION SET". The FDA issued a decision of Substantially Equivalent on April 3, 2014. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Emed Technologies Corporation has at least 10 other 510(k) clearances on record.