Gambro AK-10 Dialysis System for High Flows
FDA 510(k) K896757 · Gambro, Inc.
510(k) numberK896757
Submission
- Device name
- Gambro AK-10 Dialysis System for High Flows
- Applicant
- Gambro, Inc.
Williamsburg, VA, US - Received
- December 1, 1989
- Decision date
- August 30, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Integrated Biomedical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K083158 | Exalis, Software Version 1.15KDI · Traditional | 06/05/2009SE |
| K072093 | Prismaflex System, Version 3.20KDI · Traditional | 02/01/2008SE |
| K070643 | Phoenix Hemodialysis Delivery System, Version 3.35KDI · Traditional | 11/02/2007SE |
| K032431 | Prisma M60/M100 SetsKDI · Special | 09/15/2003SE |
| K896758 | Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional | 09/28/1990SE |
| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | 07/27/1990SE |
| K900918 | Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional | 07/16/1990SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | 05/11/1989SE |
| K890112 | Engstrom Eliza + CO2 AnalyzerCCK · Traditional | 03/15/1989SE |
| K890111 | Gambro Alwall Gfe 8 & 9 Hollow Fiber DialyzerFJI · Traditional | 02/08/1989SE |
Questions and answers
When was Gambro AK-10 Dialysis System for High Flows cleared by the FDA?
Gambro AK-10 Dialysis System for High Flows (K896757) received a 510(k) decision of Substantially Equivalent on August 30, 1990, 272 days after the submission was received.
What is the product code of K896757?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.