510(k) K894019

RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE by Resound Corp. — Product Code KHL

K894019 is an FDA 510(k) premarket notification submitted by Resound Corp. for the device "RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE". The FDA issued a decision of Substantially Equivalent on September 21, 1989. The device falls under product code KHL (Hearing Aid, Master), a Class II device regulated under 21 CFR 874.3330. Resound Corp. has at least 10 other 510(k) clearances on record.