510(k) K160305 · LBI Unit, Neonatal Phototherapy
neoBLUE® LED Phototherapy System
| Applicant | Natus Medical Incorporated, Seattle WA, US |
| Decision | Substantially Equivalent, May 27, 2016 |
| Received | Feb 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160305
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.