Name: Predicase
Price: 199 USD

K-number	K200319
Device name	HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
Applicant	Deroyal Industries, Inc.
Product code	FMT
Device class	Class II
Decision date	Apr 2, 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 Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable

Everything you need for a 510(k) submission. Nothing you don't.