K240394
- 510(k) number
- K240394
- Device name
- multiFlux 1000 (F00012408)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2024-05-31
- Date received
- 2024-02-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240394.pdf
Official FDA record: K240394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.