510(k) K925006 ยท FMT Warmer, Infant Radiant
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
| Applicant | Deroyal Industries, Inc., Powell TN, US |
| Decision | Substantially Equivalent, Jan 31, 1994 |
| Received | Oct 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2015 | DeRoyal Industries Inc HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only. Terminated |
FMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.