510(k) K810605 ยท FKR Subsystem, Proportioning
CHEMATIC BICARBONATE DIALYSATE SYSTEM
| Applicant | Trimedyne, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jun 16, 1981 |
| Received | Mar 6, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810605
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.