510(k) K181360

ON-Q* Pump with Bolus by Halyard Health — Product Code MEB

K181360 is an FDA 510(k) premarket notification submitted by Halyard Health for the device "ON-Q* Pump with Bolus". The FDA issued a decision of Substantially Equivalent on March 22, 2019. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Halyard Health has at least 10 other 510(k) clearances on record.