The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Hydro-temp Nicu And Skin Surface Temperature Senso.
| Device ID | K925006 |
| 510k Number | K925006 |
| Device Name: | HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO |
| Classification | Warmer, Infant Radiant |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-02 |
| Decision Date | 1994-01-31 |