K243607
- 510(k) number
- K243607
- Device name
- Moda-flx Hemodialysis System Cartridge (102121-001 )
- Applicant
- Diality, Inc. CA · US
- Product code
- FJK — Set, Tubing, Blood, With And Without Anti-Regurgitat
- Decision date
- 2024-12-20
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243607.pdf
Official FDA record: K243607
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.