510(k) K191425 ยท FMT Warmer, Infant Radiant
Hydro-Temp Neonatal Skin Temperature Probe Cover
| Applicant | Deroyal Industries, Inc., Powell TN, US |
| Decision | Substantially Equivalent, Jan 21, 2020 |
| Received | May 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191425
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.