K-number	K221064
Device name	Nuheara IQbuds 2 PRO Hearing Aid
Applicant	Nuheara Limited
Product code	QUH
Device class	Class II
Decision date	Oct 30, 2022
Decision	Substantially Equivalent
Regulation	874.3325

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Source

View the full FDA submission: accessdata.fda.gov

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Nuheara IQbuds 2 PRO Hearing Aid

Everything you need for a 510(k) submission. Nothing you don't.