K-number	K193520
Device name	EVA 15 Insufflator
Applicant	Palliare , Ltd.
Product code	HIF
Device class	Class II
Decision date	Jul 23, 2020
Decision	Substantially Equivalent
Regulation	884.1730

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Source

View the full FDA submission: accessdata.fda.gov

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EVA 15 Insufflator

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