PE485R FM Receiver Used W/PE481FST FM Transmitter
FDA 510(k) K881099 · Phonic Ear, Inc.
510(k) numberK881099
Submission
- Device name
- PE485R FM Receiver Used W/PE481FST FM Transmitter
- Applicant
- Phonic Ear, Inc.
Mill Valley, CA, US - Received
- March 15, 1988
- Decision date
- June 7, 1988
- 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 |
|---|---|---|
| K043090 | Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field SystemsLZI · Traditional | 12/23/2004SE |
| K974658 | Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver…EPF · Traditional | 02/25/1998SE |
| K974287 | FM Receiver - Auditory TrainerEPF · Traditional | 02/10/1998SE |
| K950730 | Group Auditory Trainer (Group Amplification System)EPF · Traditional | 06/30/1995SE |
| K940313 | Phonic EarEPF · Traditional | 03/22/1994SE |
| K923234 | Pe 400IR, Pe 400T, Pe 400EEPF · Traditional | 09/29/1992SE |
| K922720 | Group Auditory Training SystemEPF · Traditional | 08/24/1992SE |
| K912356 | Group Auditory Trainer,Fm ReceiverEPF · Traditional | 08/15/1991SE |
| K893431 | Auditory Trainer PE150R FM ReceiverEPF · Traditional | 08/21/1989SE |
| K882409 | PE100R FM Receiver Used W/PE100T FM TransmitterEPF · Traditional | 07/05/1988SE |
Questions and answers
When was PE485R FM Receiver Used W/PE481FST FM Transmitter cleared by the FDA?
PE485R FM Receiver Used W/PE481FST FM Transmitter (K881099) received a 510(k) decision of Substantially Equivalent on June 7, 1988, 84 days after the submission was received.
What is the product code of K881099?
The FDA product code is EPF – Hearing Aid, Group And Auditory Trainer, a Class II (moderate risk) device regulated under 21 CFR 874.3320.