K200319 is an FDA 510(k) clearance for the HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable. 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 April 2, 2020, 55 days after receiving the submission on February 7, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K200319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2020 |
| Decision Date | April 02, 2020 |
| Days to Decision | 55 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 |