K-number	DEN170001
Device name	Precision Flow® HVNI
Applicant	Vapotherm, Inc.
Product code	QAV
Device class	Class II
Decision date	Apr 10, 2018
Decision	Not Substantially Equivalent
Regulation	868.5454

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Source

View the full FDA submission: accessdata.fda.gov

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Precision Flow® HVNI

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