K-number	K213841
Device name	ENEO TOTALE (Model: ENEOT947)
Applicant	Premier North America, Inc.
Product code	OHS
Device class	Class II
Decision date	Jan 6, 2022
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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ENEO TOTALE (Model: ENEOT947)

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