Pump Connectivity Interface
FDA 510(k) K040985 · Baxter Healthcare Corp
510(k) numberK040985
Submission
- Device name
- Pump Connectivity Interface
- Applicant
- Baxter Healthcare Corp
Deerfield Lake, IL, US - Received
- April 15, 2004
- Decision date
- November 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K230665 | Dose IQ Safety SoftwarePHC · Traditional | 03/29/2024SE |
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Questions and answers
When was Pump Connectivity Interface cleared by the FDA?
Pump Connectivity Interface (K040985) received a 510(k) decision of Substantially Equivalent on November 30, 2004, 229 days after the submission was received.
What is the product code of K040985?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.