510(k) K923234

PE 400IR, PE 400T, PE 400E by Phonic Ear, Inc. — Product Code EPF

K923234 is an FDA 510(k) premarket notification submitted by Phonic Ear, Inc. for the device "PE 400IR, PE 400T, PE 400E". The FDA issued a decision of Substantially Equivalent on September 29, 1992. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320. Phonic Ear, Inc. has at least 10 other 510(k) clearances on record.