510(k) K182859 · FMZ Incubator, Neonatal
Babyleo TN500
| Applicant | Dragerwerk AG & CO Kgaa, Lübeck, DE |
| Decision | Substantially Equivalent, Feb 22, 2019 |
| Received | Oct 11, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182859
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.