K-number	K183201
Device name	Hearing Healthcare Pro
Applicant	Db Diagnostic Systems, Inc.
Product code	ETY
Device class	Class II
Decision date	Mar 6, 2019
Decision	Substantially Equivalent
Regulation	874.1090

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Source

View the full FDA submission: accessdata.fda.gov

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Hearing Healthcare Pro

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