510(k) K162821 · FMZ Incubator, Neonatal
Babyleo TN500
| Applicant | Draegerwerk AG & CO Kgaa, Lübeck, DE |
| Decision | Substantially Equivalent, Jun 23, 2017 |
| Received | Oct 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162821
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.