Pack H Hemodialysis Urea Kinetic Modeling Software Program
FDA 510(k) K955423 · Fresenius USA, Inc.
510(k) numberK955423
Submission
- Device name
- Pack H Hemodialysis Urea Kinetic Modeling Software Program
- Applicant
- Fresenius USA, Inc.
Walnut Creek, CA, US - Received
- November 28, 1995
- Decision date
- June 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FKP – System, Dialysate Delivery, Single Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K930181 | Biopure Dialysate Concentrate Mix Syst/ConcentrateFKP · Traditional | Fresenius USA, Inc. | 11/29/1995SE |
More from Fresenius USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992275 | Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol…KDI · Special | 08/04/1999SE |
| K970700 | Fresenius Polysulfone Hemodialyzers, Both Low and High FluxMSE · Traditional | 09/15/1998SE |
| K974584 | Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSKDI · Traditional | 05/14/1998SE |
| K973378 | C.A.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model…CAC · Traditional | 11/03/1997SE |
| K961465 | 2008H on Line Clearance MonitorKDI · Traditional | 07/03/1997SE |
| K961706 | P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell SeparatorLKN · Traditional | 07/31/1996SE |
| K955762 | Packpd Peritoneal Dialysis Urea Kinetic Modeling Software ProgramKPF · Traditional | 07/31/1996SE |
| K941460 | Fresenius Blood Temperature MonitorMQS · Traditional | 07/03/1996SE |
| K944767 | Dialysis Machine with Dialysate UltrafilterFIP · Traditional | 11/29/1995SE |
| K930181 | Biopure Dialysate Concentrate Mix Syst/ConcentrateFKP · Traditional | 11/29/1995SE |
Questions and answers
When was Pack H Hemodialysis Urea Kinetic Modeling Software Program cleared by the FDA?
Pack H Hemodialysis Urea Kinetic Modeling Software Program (K955423) received a 510(k) decision of Substantially Equivalent on June 13, 1996, 198 days after the submission was received.
What is the product code of K955423?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.