Group Auditory Trainer HC 431R
FDA 510(k) K771357 · Hc Electronics
510(k) numberK771357
Submission
- Device name
- Group Auditory Trainer HC 431R
- Applicant
- Hc Electronics
Mchenry, IL, US - Received
- July 22, 1977
- Decision date
- July 29, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K810031 | Stereo Auditory Trainer (Model PM228)EPF · Traditional | 03/04/1981SE |
| K810030 | Post-Auricular Hearing Aid (#PE830)ESD · Traditional | 01/14/1981SE |
| K800340 | Phonic Ear, Model 841LESD · Traditional | 02/26/1980SE |
| K782053 | Hearing Aid, Post-AuricularESD · Traditional | 12/15/1978SE |
| K780936 | Phonic EarEPF · Traditional | 06/22/1978SE |
| K780363 | Phonic EarESD · Traditional | 03/21/1978SE |
| K772347 | Phonic Mirror Handivoice Model 120 · Traditional | 01/11/1978SE |
| K772346 | Phonic Mirror Handivocie Model 110 · Traditional | 01/11/1978SE |
| K771356 | Post-Auricular Hearing Aid HC 880ESD · Traditional | 07/29/1977SE |
Questions and answers
When was Group Auditory Trainer HC 431R cleared by the FDA?
Group Auditory Trainer HC 431R (K771357) received a 510(k) decision of Substantially Equivalent on July 29, 1977, 7 days after the submission was received.
What is the product code of K771357?
The FDA product code is EPF – Hearing Aid, Group And Auditory Trainer, a Class II (moderate risk) device regulated under 21 CFR 874.3320.