510(k) K172154 ยท FMZ Incubator, Neonatal
Isolette 8000 plus
| Applicant | Draeger Medical Sytems, Inc., Telford PA, US |
| Decision | Substantially Equivalent, Apr 19, 2018 |
| Received | Jul 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172154
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.