Submission Details
| 510(k) Number | K191425 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Hydro-Temp Neonatal Skin Temperature Probe Cover
Jan 2020
Decision
237d
Days
Class 2
Risk
About This 510(k) Submission
K191425 is an FDA 510(k) clearance for the Hydro-Temp Neonatal Skin Temperature Probe Cover, 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 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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