510(k) K242269 ยท ONW Hemodialysis System For Home Use
SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
| Applicant | Quanta Dialysis Technologies, Ltd., Warwick, GB |
| Decision | Substantially Equivalent, Nov 1, 2024 |
| Received | Aug 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242269
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.