510(k) K182977 ยท FMZ Incubator, Neonatal
Isolette 8000 Plus
| Applicant | Draeger Medical Systems, Inc., Telford PA, US |
| Decision | Substantially Equivalent, Nov 21, 2018 |
| Received | Oct 26, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182977
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.