510(k) K200319 ยท FMT Warmer, Infant Radiant
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
| Applicant | Deroyal Industries, Inc., Powell TN, US |
| Decision | Substantially Equivalent, Apr 2, 2020 |
| Received | Feb 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200319
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.