MP0400 Adult, Peristalic Infusion Pump
FDA 510(k) K853814 · Medex, Inc.
510(k) numberK853814
Submission
- Device name
- MP0400 Adult, Peristalic Infusion Pump
- Applicant
- Medex, Inc.
Hilliard, OH, US - Received
- September 12, 1985
- Decision date
- January 16, 1986
- Decision
- Substantially Equivalent (SESE)
- 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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| 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 |
| K955231 | Medfusion Model 2001 Syringe Infusion PumpFRN · Traditional | 07/18/1996ST |
| K961404 | MX960 Reusable Pressure TransducerDRS · Traditional | 06/27/1996SE |
Questions and answers
When was MP0400 Adult, Peristalic Infusion Pump cleared by the FDA?
MP0400 Adult, Peristalic Infusion Pump (K853814) received a 510(k) decision of Substantially Equivalent on January 16, 1986, 126 days after the submission was received.
What is the product code of K853814?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.