Submission Details
| 510(k) Number | K200319 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
Apr 2020
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 880.5130.
Device Classification
| Product Code | FMT — Warmer, Infant Radiant |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5130 |
Manufacturer
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