K925006 is an FDA 510(k) clearance for the HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on January 31, 1994, 486 days after receiving the submission on October 2, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K925006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1992 |
| Decision Date | January 31, 1994 |
| Days to Decision | 486 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMT — Warmer, Infant Radiant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5130 |