TDR-4 Monaural Hearing Aid/Wireless FM Receiver
FDA 510(k) K915383 · Telex Communications, Inc.
510(k) numberK915383
Submission
- Device name
- TDR-4 Monaural Hearing Aid/Wireless FM Receiver
- Applicant
- Telex Communications, Inc.
Minneapolis, MN, US - Received
- November 29, 1991
- Decision date
- January 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EPF – Hearing Aid, Group And Auditory Trainer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3320
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133352 | Hypersound Audio System (HSS)EPF · Traditional | Hypersound Health, Inc. | 02/12/2014SE |
| K982683 | Telex Select 1-40 with Adaptive CompressionEPF · Traditional | Telex Communications, Inc. | 10/06/1998SE |
| K974658 | Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver…EPF · Traditional | Phonic Ear, Inc. | 02/25/1998SE |
| K974287 | FM Receiver - Auditory TrainerEPF · Traditional | Phonic Ear, Inc. | 02/10/1998SE |
| K970687 | Williams Sound, Personal FM, Hearing HelperEPF · Traditional | Williams Sound, LLC | 05/02/1997SE |
| K970665 | Williams Sound, Personal FM, Hearing HelperEPF · Traditional | Williams Sound, LLC | 05/02/1997SE |
| K960567 | HF Mega EarEPF · Traditional | Maxi-Aids, Inc. | 10/16/1996SE |
| K950730 | Group Auditory Trainer (Group Amplification System)EPF · Traditional | Phonic Ear, Inc. | 06/30/1995SE |
| K941768 | Phonak Microvox Resonal FM SystemEPF · Traditional | Phonak, Inc. | 06/24/1994SE |
| K940313 | Phonic EarEPF · Traditional | Phonic Ear, Inc. | 03/22/1994SE |
More from Phonic Ear, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984243 | Telex Tinnitus-CompanionKLW · Traditional | 01/21/1999SE |
| K982683 | Telex Select 1-40 with Adaptive CompressionEPF · Traditional | 10/06/1998SE |
| K964639 | Telex In-The-Ear Custom Hearing Aid with Threshold Compression-IiESD · Traditional | 01/21/1997SE |
| K963915 | Telex In-The-Ear Custom Hearing Aid with Threshold CompressionESD · Traditional | 11/08/1996SE |
| K961143 | Telex Select 2-40 with Adaptive Compression S2-40ESD · Traditional | 05/07/1996SE |
| K954579 | Telex 349 Multi Cros W/Adapive CompressionESD · Traditional | 12/08/1995SE |
| K943961 | The Model Acappella in the Ear Hearing AidESD · Traditional | 05/15/1995SE |
| K935048 | Artisan Programmer & Hearing AidLRB · Traditional | 02/09/1994SE |
| K935366 | Binaural Hearing AidESD · Traditional | 01/13/1994SE |
| K933579 | Memorex Artisan System/Artisan Programmer and Custom Hearing AidESD · Traditional | 08/23/1993SE |
Questions and answers
When was TDR-4 Monaural Hearing Aid/Wireless FM Receiver cleared by the FDA?
TDR-4 Monaural Hearing Aid/Wireless FM Receiver (K915383) received a 510(k) decision of Substantially Equivalent on January 17, 1992, 49 days after the submission was received.
What is the product code of K915383?
The FDA product code is EPF – Hearing Aid, Group And Auditory Trainer, a Class II (moderate risk) device regulated under 21 CFR 874.3320.