510(k) K243371 ยท FKX System, Peritoneal, Automatic Delivery
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
| Applicant | Byonyks Pvt, Ltd., Lahore, PK |
| Decision | Substantially Equivalent, May 16, 2025 |
| Received | Oct 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243371
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.