Biopure Dialysate Concentrate Mix Syst/Concentrate
FDA 510(k) K930181 · Fresenius USA, Inc.
510(k) numberK930181
Submission
- Device name
- Biopure Dialysate Concentrate Mix Syst/Concentrate
- Applicant
- Fresenius USA, Inc.
Walnut Creek, CA, US - Received
- January 14, 1993
- Decision date
- November 29, 1995
- 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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| 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 |
| K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software ProgramFKP · Traditional | 06/13/1996SE |
| K944767 | Dialysis Machine with Dialysate UltrafilterFIP · Traditional | 11/29/1995SE |
Questions and answers
When was Biopure Dialysate Concentrate Mix Syst/Concentrate cleared by the FDA?
Biopure Dialysate Concentrate Mix Syst/Concentrate (K930181) received a 510(k) decision of Substantially Equivalent on November 29, 1995, 1,049 days after the submission was received.
What is the product code of K930181?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.