Prisma M60/M100 Sets
FDA 510(k) K032431 · Gambro, Inc.
510(k) numberK032431
Submission
- Device name
- Prisma M60/M100 Sets
- Applicant
- Gambro, Inc.
Lakewood, CO, US - Received
- August 6, 2003
- Decision date
- September 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| 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 Prisma M60/M100 Sets cleared by the FDA?
Prisma M60/M100 Sets (K032431) received a 510(k) decision of Substantially Equivalent on September 15, 2003, 40 days after the submission was received.
What is the product code of K032431?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.