Novum IQ Syringe Pump (40800BAXUS)
FDA 510(k) K242390 · Baxter Healthcare Corporation
510(k) numberK242390
Submission
- Device name
- Novum IQ Syringe Pump (40800BAXUS)
- Applicant
- Baxter Healthcare Corporation
Deerfield Lake, IL, US - Received
- August 12, 2024
- Decision date
- September 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Novum IQ Syringe Pump (40800BAXUS) cleared by the FDA?
Novum IQ Syringe Pump (40800BAXUS) (K242390) received a 510(k) decision of Substantially Equivalent on September 5, 2024, 24 days after the submission was received.
What is the product code of K242390?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.