K-number	DEN210033
Device name	Lenire Tinnitus Treatment Device
Applicant	Neuromod Devices Limited
Product code	QVN
Device class	Class II
Decision date	Mar 6, 2023
Decision	Not Substantially Equivalent
Regulation	874.3410

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Source

View the full FDA submission: accessdata.fda.gov

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Lenire Tinnitus Treatment Device

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