510(k) K915398

TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER by Telex Communications, Inc. — Product Code EPF

K915398 is an FDA 510(k) premarket notification submitted by Telex Communications, Inc. for the device "TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER". The FDA issued a decision of Substantially Equivalent on January 17, 1992. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320. Telex Communications, Inc. has at least 10 other 510(k) clearances on record.