Hydro-Temp Neonatal Skin Temperature Probe Cover
FDA 510(k) K191425 · Deroyal Industries, Inc.
510(k) numberK191425
Submission
- Device name
- Hydro-Temp Neonatal Skin Temperature Probe Cover
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- May 29, 2019
- Decision date
- January 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
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Questions and answers
When was Hydro-Temp Neonatal Skin Temperature Probe Cover cleared by the FDA?
Hydro-Temp Neonatal Skin Temperature Probe Cover (K191425) received a 510(k) decision of Substantially Equivalent on January 21, 2020, 237 days after the submission was received.
What is the product code of K191425?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.