510(k) K984547

DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS by Resound Corp. — Product Code EWO

K984547 is an FDA 510(k) premarket notification submitted by Resound Corp. for the device "DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS". The FDA issued a decision of Substantially Equivalent on March 19, 1999. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Resound Corp. has at least 10 other 510(k) clearances on record.