K-number	K191425
Device name	Hydro-Temp Neonatal Skin Temperature Probe Cover
Applicant	Deroyal Industries, Inc.
Product code	FMT
Device class	Class II
Decision date	Jan 21, 2020
Decision	Substantially Equivalent
Regulation	880.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Hydro-Temp Neonatal Skin Temperature Probe Cover

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