K233557
- 510(k) number
- K233557
- Device name
- HemoCare Hemodialysis System
- Applicant
- Deka Research and Development NH · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2024-07-12
- Date received
- 2023-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233557.pdf
Official FDA record: K233557
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.