The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Hydro-temp Neonatal Skin Temperature Probe Cover.
| Device ID | K191425 |
| 510k Number | K191425 |
| Device Name: | Hydro-Temp Neonatal Skin Temperature Probe Cover |
| Classification | Warmer, Infant Radiant |
| Applicant | DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 |
| Contact | Sarah Bennett |
| Correspondent | Sarah Bennett DeRoyal Industries, Inc. 200 DeBusk Lane 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 | 2019-05-29 |
| Decision Date | 2020-01-21 |
| Summary: | summary |