K-number	K150491
Device name	ER36 Series OAE Test System
Applicant	Etymotic Research, Inc.
Product code	EWO
Device class	Class II
Decision date	Mar 26, 2015
Decision	Substantially Equivalent
Regulation	874.1050

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Source

View the full FDA submission: accessdata.fda.gov

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ER36 Series OAE Test System

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