K231534
- 510(k) number
- K231534
- Device name
- 5008X Hemodialysis System
- Applicant
- Fresenius Medical Care MA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2024-02-02
- Date received
- 2023-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231534.pdf
Official FDA record: K231534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.