510(k) K913494

TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC by Telex Communications, Inc. — Product Code EPF

K913494 is an FDA 510(k) premarket notification submitted by Telex Communications, Inc. for the device "TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC". The FDA issued a decision of Substantially Equivalent on November 1, 1991. 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.