Name: Predicase
Price: 199 USD

K-number	K111618
Device name	AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
Applicant	Natus Medical Incorporated
Product code	EWO
Device class	Class II
Decision date	Dec 28, 2011
Decision	Substantially Equivalent
Regulation	874.1050

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Source

View the full FDA submission: accessdata.fda.gov

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AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

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