HF Mega Ear
FDA 510(k) K960567 · Maxi-Aids, Inc.
510(k) numberK960567
Submission
- Device name
- HF Mega Ear
- Applicant
- Maxi-Aids, Inc.
Farmingdale, NY, US - Received
- February 9, 1996
- Decision date
- October 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K923234 | Pe 400IR, Pe 400T, Pe 400EEPF · Traditional | Phonic Ear, Inc. | 09/29/1992SE |
More from Phonic Ear, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K041778 | Reizen Talking Blood Pressure Monitor, Model #SF860TDXN · Abbreviated | 08/31/2004SE |
Questions and answers
When was HF Mega Ear cleared by the FDA?
HF Mega Ear (K960567) received a 510(k) decision of Substantially Equivalent on October 16, 1996, 250 days after the submission was received.
What is the product code of K960567?
The FDA product code is EPF – Hearing Aid, Group And Auditory Trainer, a Class II (moderate risk) device regulated under 21 CFR 874.3320.