K-number	K222551
Device name	Humask Pro Vision, Humask Pro Vision 3000
Applicant	Entreprise Premont, Inc.
Product code	FXX
Device class	Class II
Decision date	Nov 10, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Humask Pro Vision, Humask Pro Vision 3000

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