K-number	K191010
Device name	Palladium High Flow Therapy System
Applicant	Vapotherm, Inc.
Product code	BTT
Device class	Class II
Decision date	Oct 10, 2019
Decision	Substantially Equivalent
Regulation	868.5450

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Source

View the full FDA submission: accessdata.fda.gov

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Palladium High Flow Therapy System

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