EPF — Hearing Aid, Group And Auditory Trainer Class II

FDA Device Classification

Classification Details

Product Code
EPF
Device Class
Class II
Regulation Number
874.3320
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K133352hypersound healthHYPERSOUND AUDIO SYSTEM (HSS)February 12, 2014
K982683telex communicationsTELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONOctober 6, 1998
K974658phonic earINFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVFebruary 25, 1998
K974287phonic earFM RECEIVER - AUDITORY TRAINERFebruary 10, 1998
K970665williams soundWILLIAMS SOUND, PERSONAL FM, HEARING HELPERMay 2, 1997
K970687williams soundWILLIAMS SOUND, PERSONAL FM, HEARING HELPERMay 2, 1997
K960567maxi-aidsHF MEGA EAROctober 16, 1996
K950730phonic earGROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)June 30, 1995
K941768phonakPHONAK MICROVOX RESONAL FM SYSTEMJune 24, 1994
K940313phonic earPHONIC EARMarch 22, 1994
K923234phonic earPE 400IR, PE 400T, PE 400ESeptember 29, 1992
K922720phonic earGROUP AUDITORY TRAINING SYSTEMAugust 24, 1992
K922570resoundRESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1August 6, 1992
K915383telex communicationsTDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVERJanuary 17, 1992
K915397telex communicationsTDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVERJanuary 17, 1992
K915384telex communicationsTDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVERJanuary 17, 1992
K915398telex communicationsTDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVERJanuary 17, 1992
K913494telex communicationsTELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM RECNovember 1, 1991
K913495telex communicationsTELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM RECNovember 1, 1991
K912356phonic earGROUP AUDITORY TRAINER,FM RECEIVERAugust 15, 1991