510(k) K982683
- Device
- TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
- Applicant
- TELEX COMMUNICATIONS, INC.
- 510(k) number
- K982683
- Product code
- EPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-10-06
- Date received
- 1998-07-31
- Regulation
- 874.3320
- Classification name
- Hearing Aid, Group And Auditory Trainer
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM SCHELLER
- Address
- 9600 Aldrich Ave. S. Minneapolis MN US 55420 55420
FDA Registration Numbers#
- 3043496923
- 3011647251
Source Documents#
Other 510(k) Records For Product Code EPF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133352 | HYPERSOUND AUDIO SYSTEM (HSS) | Hypersound Health, Inc. | 2014-02-12 |
| K974658 | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT | Phonic Ear, Inc. | 1998-02-25 |
| K974287 | FM RECEIVER - AUDITORY TRAINER | Phonic Ear, Inc. | 1998-02-10 |
| K970687 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | Williams Sound, LLC | 1997-05-02 |
| K970665 | WILLIAMS SOUND, PERSONAL FM, HEARING HELPER | Williams Sound, LLC | 1997-05-02 |
| K960567 | HF MEGA EAR | Maxi-Aids, Inc. | 1996-10-16 |
| K950730 | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) | Phonic Ear, Inc. | 1995-06-30 |
| K941768 | PHONAK MICROVOX RESONAL FM SYSTEM | Phonak, Inc. | 1994-06-24 |
| K940313 | PHONIC EAR | Phonic Ear, Inc. | 1994-03-22 |
| K923234 | PE 400IR, PE 400T, PE 400E | Phonic Ear, Inc. | 1992-09-29 |
| K922720 | GROUP AUDITORY TRAINING SYSTEM | Phonic Ear, Inc. | 1992-08-24 |
| K922570 | RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 | Resound Corp. | 1992-08-06 |
| K915398 | TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER | Telex Communications, Inc. | 1992-01-17 |
| K915397 | TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER | Telex Communications, Inc. | 1992-01-17 |
| K915384 | TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER | Telex Communications, Inc. | 1992-01-17 |
Legacy Summary#
summary
FDA Review#
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