FDA Product Code
FDA Product Code EPF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3320
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133352 | HYPERSOUND AUDIO SYSTEM (HSS) | Hypersound Health, Inc. | 2014-02-12 | Traditional | PDF ↗ |
| K982683 | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION | Telex Communications, Inc. | 1998-10-06 | Traditional | PDF ↗ |
| K974658 | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT | Phonic Ear, Inc. | 1998-02-25 | Traditional | PDF ↗ |
| K974287 | FM RECEIVER - AUDITORY TRAINER | Phonic Ear, Inc. | 1998-02-10 | Traditional | PDF ↗ |
| K970687 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | Williams Sound, LLC | 1997-05-02 | Traditional | PDF ↗ |
| K970665 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | Williams Sound, LLC | 1997-05-02 | Traditional | PDF ↗ |
| K960567 | HF MEGA EAR | Maxi-Aids, Inc. | 1996-10-16 | Traditional | PDF ↗ |
| K950730 | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) | Phonic Ear, Inc. | 1995-06-30 | Traditional | PDF ↗ |
| K941768 | PHONAK MICROVOX RESONAL FM SYSTEM | Phonak, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K940313 | PHONIC EAR | Phonic Ear, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K923234 | PE 400IR, PE 400T, PE 400E | Phonic Ear, Inc. | 1992-09-29 | Traditional | PDF ↗ |
| K922720 | GROUP AUDITORY TRAINING SYSTEM | Phonic Ear, Inc. | 1992-08-24 | Traditional | PDF ↗ |
| K922570 | RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 | Resound Corp. | 1992-08-06 | Traditional | PDF ↗ |
| K915397 | TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER | Telex Communications, Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K915398 | TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER | Telex Communications, Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K915383 | TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER | Telex Communications, Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K915384 | TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER | Telex Communications, Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K913494 | TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC | Telex Communications, Inc. | 1991-11-01 | Traditional | PDF ↗ |
| K913495 | TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC | Telex Communications, Inc. | 1991-11-01 | Traditional | PDF ↗ |
| K912356 | GROUP AUDITORY TRAINER,FM RECEIVER | Phonic Ear, Inc. | 1991-08-15 | Traditional | PDF ↗ |
| K893431 | AUDITORY TRAINER PE150R FM RECEIVER | Phonic Ear, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K882409 | PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER | Phonic Ear, Inc. | 1988-07-05 | Traditional | PDF ↗ |
| K881099 | PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER | Phonic Ear, Inc. | 1988-06-07 | Traditional | PDF ↗ |
| K862773 | PHONIC EAR, MODEL PE475R | Phonic Ear, Inc. | 1986-10-09 | Traditional | PDF ↗ |
| K832190 | METAVOX MV-1000 AUDITORY TRAINER | Metavox, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K832080 | PHONIC EAR PE 467R-PE 461T | Phonic Ear, Inc. | 1983-08-01 | Traditional | PDF ↗ |
| K821691 | STIMRITE | Biotone International, Inc. | 1982-08-25 | Traditional | PDF ↗ |
| K821511 | POWERED MUSCLE STIMULATOR | High Country Ent. | 1982-08-16 | Traditional | PDF ↗ |
| K810031 | STEREO AUDITORY TRAINER (MODEL PM228) | Hc Electronics | 1981-03-04 | Traditional | PDF ↗ |
| K780936 | PHONIC EAR | Hc Electronics | 1978-06-22 | Traditional | PDF ↗ |
| K771671 | AUDITORY TRAINER | Accutone, Inc. | 1977-09-12 | Traditional | PDF ↗ |
| K771357 | GROUP AUDITORY TRAINER HC 431R | Hc Electronics | 1977-07-29 | Traditional | PDF ↗ |
Product code EPF · Class II · Ear, Nose, Throat. Data: openFDA.