K233798
- 510(k) number
- K233798
- Device name
- Moda-flx Hemodialysis System and Cartridge
- Applicant
- Diality, Inc. CA · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2024-08-02
- Date received
- 2023-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K233798.pdf
Official FDA record: K233798
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.