510(k) K111618

AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION by Natus Medical Incorporated — Product Code EWO

K111618 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated for the device "AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION". The FDA issued a decision of Substantially Equivalent on December 28, 2011. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Natus Medical Incorporated has at least 9 other 510(k) clearances on record.