510(k) K981085 ยท FIP Subsystem, Water Purification
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
| Applicant | Gambro Healthcare, Lakewood CO, US |
| Decision | Substantially Equivalent, May 18, 1998 |
| Received | Mar 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981085
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.