510(k) K211122

Novum IQ Large Volume Pump by Baxter Healthcare Corporation — Product Code FRN

K211122 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Novum IQ Large Volume Pump". The FDA issued a decision of Substantially Equivalent on March 29, 2024. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.