Auditory Trainer
FDA 510(k) K771671 · Accutone, Inc.
510(k) numberK771671
Submission
- Device name
- Auditory Trainer
- Applicant
- Accutone, Inc.
Mchenry, IL, US - Received
- September 1, 1977
- Decision date
- September 12, 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 |
Questions and answers
When was Auditory Trainer cleared by the FDA?
Auditory Trainer (K771671) received a 510(k) decision of Substantially Equivalent on September 12, 1977, 11 days after the submission was received.
What is the product code of K771671?
The FDA product code is EPF – Hearing Aid, Group And Auditory Trainer, a Class II (moderate risk) device regulated under 21 CFR 874.3320.