K-number	DEN200042
Device name	BrainTemp Neonate System (BTNeo System)
Applicant	Brain Temp, Inc.
Product code	QSL
Device class	Class II
Decision date	Mar 29, 2022
Decision	Not Substantially Equivalent
Regulation	882.1565

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View the full FDA submission: accessdata.fda.gov

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BrainTemp Neonate System (BTNeo System)

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