Panels › Ear, Nose, Throat › Product code EPF · Class 2
Hearing Aid, Group And Auditory Trainer
Regulation 874.3320
0510(k)s in 12 months (32 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EPF
| Company | 510(k)s | Recalls |
|---|---|---|
| Phonic Ear, Inc. | 12 | 0 |
| Telex Communications, Inc. | 7 | 0 |
| Hc Electronics | 3 | 0 |
| Williams Sound, LLC | 2 | 0 |
| Accutone, Inc. | 1 | 0 |
| Biotone International, Inc. | 1 | 0 |
| High Country Ent. | 1 | 0 |
| Hypersound Health, Inc. | 1 | 0 |
| Maxi-Aids, Inc. | 1 | 0 |
| Metavox, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2014 | K133352 | HYPERSOUND AUDIO SYSTEM (HSS) Hypersound Health, Inc. | EPF |
| Oct 6, 1998 | K982683 | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION Telex Communications, Inc. | EPF |
| Feb 25, 1998 | K974658 | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT Phonic Ear, Inc. | EPF |
| Feb 10, 1998 | K974287 | FM RECEIVER - AUDITORY TRAINER Phonic Ear, Inc. | EPF |
| May 2, 1997 | K970687 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER Williams Sound, LLC | EPF |
| May 2, 1997 | K970665 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER Williams Sound, LLC | EPF |
| Oct 16, 1996 | K960567 | HF MEGA EAR Maxi-Aids, Inc. | EPF |
| Jun 30, 1995 | K950730 | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) Phonic Ear, Inc. | EPF |
| Jun 24, 1994 | K941768 | PHONAK MICROVOX RESONAL FM SYSTEM Phonak, Inc. | EPF |
| Mar 22, 1994 | K940313 | PHONIC EAR Phonic Ear, Inc. | EPF |
| Sep 29, 1992 | K923234 | PE 400IR, PE 400T, PE 400E Phonic Ear, Inc. | EPF |
| Aug 24, 1992 | K922720 | GROUP AUDITORY TRAINING SYSTEM Phonic Ear, Inc. | EPF |
| Aug 6, 1992 | K922570 | RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 Resound Corp. | EPF |
| Jan 17, 1992 | K915398 | TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER Telex Communications, Inc. | EPF |
| Jan 17, 1992 | K915397 | TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER Telex Communications, Inc. | EPF |
| Jan 17, 1992 | K915384 | TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER Telex Communications, Inc. | EPF |
| Jan 17, 1992 | K915383 | TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER Telex Communications, Inc. | EPF |
| Nov 1, 1991 | K913495 | TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC Telex Communications, Inc. | EPF |
| Nov 1, 1991 | K913494 | TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC Telex Communications, Inc. | EPF |
| Aug 15, 1991 | K912356 | GROUP AUDITORY TRAINER,FM RECEIVER Phonic Ear, Inc. | EPF |
| Aug 21, 1989 | K893431 | AUDITORY TRAINER PE150R FM RECEIVER Phonic Ear, Inc. | EPF |
| Jul 5, 1988 | K882409 | PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER Phonic Ear, Inc. | EPF |
| Jun 7, 1988 | K881099 | PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER Phonic Ear, Inc. | EPF |
| Oct 9, 1986 | K862773 | PHONIC EAR, MODEL PE475R Phonic Ear, Inc. | EPF |
| Sep 12, 1983 | K832190 | METAVOX MV-1000 AUDITORY TRAINER Metavox, Inc. | EPF |
| Aug 1, 1983 | K832080 | PHONIC EAR PE 467R-PE 461T Phonic Ear, Inc. | EPF |
| Aug 25, 1982 | K821691 | STIMRITE Biotone International, Inc. | EPF |
| Aug 16, 1982 | K821511 | POWERED MUSCLE STIMULATOR High Country Ent. | EPF |
| Mar 4, 1981 | K810031 | STEREO AUDITORY TRAINER (MODEL PM228) Hc Electronics | EPF |
| Jun 22, 1978 | K780936 | PHONIC EAR Hc Electronics | EPF |
| Sep 12, 1977 | K771671 | AUDITORY TRAINER Accutone, Inc. | EPF |
| Jul 29, 1977 | K771357 | GROUP AUDITORY TRAINER HC 431R Hc Electronics | EPF |
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