K242269
- 510(k) number
- K242269
- Device name
- SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
- Applicant
- Quanta Dialysis Technologies, Ltd. GB
- Product code
- ONW — Hemodialysis System For Home Use
- Decision date
- 2024-11-01
- Date received
- 2024-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242269.pdf
Official FDA record: K242269
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.