Medfusion Model 2001 Syringe Infusion Pump
FDA 510(k) K955231 · Medex, Inc.
510(k) numberK955231
Submission
- Device name
- Medfusion Model 2001 Syringe Infusion Pump
- Applicant
- Medex, Inc.
Duluth, GA, US - Received
- November 14, 1995
- Decision date
- July 18, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
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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| 510(k) | Device | Decision |
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| K242255 | Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional | 04/29/2025SE |
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| K042432 | Pharmguard Toolbox, Model G6000782FRN · Traditional | 01/04/2005SE |
| K040899 | Medex 3000 Series MR Syringe Infusion PumpFRN · Traditional | 04/30/2004SE |
| K020780 | Transtar Intracranial Pressure Transducer, Model MX950ICPGWM · Abbreviated | 05/20/2002SE |
| K000328 | Medex 3000 Series MRI Compatible Syringe Infusion PumpFRN · Traditional | 05/09/2000SE |
| K982640 | Medex 3000 Series Syringe Infusion PumpFRN · Traditional | 04/06/1999ST |
| K982123 | Contrast Control DeviceFPA · Traditional | 07/21/1998SE |
| K961404 | MX960 Reusable Pressure TransducerDRS · Traditional | 06/27/1996SE |
| K961527 | MX703 and MX730 Continuous Flush DevicesKRA · Traditional | 06/06/1996SE |
Questions and answers
When was Medfusion Model 2001 Syringe Infusion Pump cleared by the FDA?
Medfusion Model 2001 Syringe Infusion Pump (K955231) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on July 18, 1996, 247 days after the submission was received.
What is the product code of K955231?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.