510(k) K864095 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
| Applicant | Gambro, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Feb 20, 1987 |
| Received | Oct 21, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864095
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.