510(k) K864083 ยท FKP System, Dialysate Delivery, Single Patient
GAMBRO BICARBONATE MONITOR BCM 10-2
| Applicant | Gambro, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Nov 6, 1986 |
| Received | Oct 20, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864083
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.