510(k) K242390

Novum IQ Syringe Pump (40800BAXUS) by Baxter Healthcare Corporation — Product Code FRN

K242390 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Novum IQ Syringe Pump (40800BAXUS)". The FDA issued a decision of Substantially Equivalent on September 5, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2024
Date Received
August 12, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type