K242390 is an FDA 510(k) clearance for the Novum IQ Syringe Pump (40800BAXUS). This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on September 5, 2024, 24 days after receiving the submission on August 12, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K242390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2024 |
| Decision Date | September 05, 2024 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |