510(k) K251619 · FMZ Incubator, Neonatal
Babyleo TN500
| Applicant | Drägerwerk AG & Co. KGaA, Luebeck, DE |
| Decision | Substantially Equivalent, Feb 13, 2026 |
| Received | May 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251619
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.