K191425 is an FDA 510(k) clearance for the Hydro-Temp Neonatal Skin Temperature Probe Cover. 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 21, 2020, 237 days after receiving the submission on May 29, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K191425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2019 |
| Decision Date | January 21, 2020 |
| Days to Decision | 237 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 |