510(k) K112247

A BAER WITH ABAER I/O FUNCTION by Natus Medical Incorporated — Product Code EWO

K112247 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated for the device "A BAER WITH ABAER I/O FUNCTION". The FDA issued a decision of Substantially Equivalent on April 2, 2012. 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.