510(k) K141446

ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, by Natus Medical Incorporated — Product Code GWJ

K141446 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated for the device "ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,". The FDA issued a decision of Substantially Equivalent on August 22, 2014. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Natus Medical Incorporated has at least 9 other 510(k) clearances on record.