EPF — Hearing Aid, Group And Auditory Trainer Class II
FDA product code EPF covers "Hearing Aid, Group And Auditory Trainer", a Class II medical device regulated under 21 CFR 874.3320. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K133352 | Hypersound Health | HYPERSOUND AUDIO SYSTEM (HSS) | Feb 12, 2014 |
| K982683 | Telex Communications | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION | Oct 6, 1998 |
| K974658 | Phonic Ear | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIV | Feb 25, 1998 |
| K974287 | Phonic Ear | FM RECEIVER - AUDITORY TRAINER | Feb 10, 1998 |
| K970665 | Williams Sound | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | May 2, 1997 |
| K970687 | Williams Sound | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | May 2, 1997 |
| K960567 | Maxi-Aids | HF MEGA EAR | Oct 16, 1996 |
| K950730 | Phonic Ear | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) | Jun 30, 1995 |
| K941768 | Phonak | PHONAK MICROVOX RESONAL FM SYSTEM | Jun 24, 1994 |
| K940313 | Phonic Ear | PHONIC EAR | Mar 22, 1994 |
| K923234 | Phonic Ear | PE 400IR, PE 400T, PE 400E | Sep 29, 1992 |
| K922720 | Phonic Ear | GROUP AUDITORY TRAINING SYSTEM | Aug 24, 1992 |
| K922570 | Resound | RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 | Aug 6, 1992 |
| K915397 | Telex Communications | TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER | Jan 17, 1992 |
| K915383 | Telex Communications | TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER | Jan 17, 1992 |
| K915398 | Telex Communications | TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER | Jan 17, 1992 |
| K915384 | Telex Communications | TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER | Jan 17, 1992 |
| K913494 | Telex Communications | TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC | Nov 1, 1991 |
| K913495 | Telex Communications | TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC | Nov 1, 1991 |
| K912356 | Phonic Ear | GROUP AUDITORY TRAINER,FM RECEIVER | Aug 15, 1991 |