Unitron Model Sound F/X +4
FDA 510(k) K964503 · Unitron Industries, Inc.
510(k) numberK964503
Submission
- Device name
- Unitron Model Sound F/X +4
- Applicant
- Unitron Industries, Inc.
Port Huron, MI, US - Received
- November 8, 1996
- Decision date
- November 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ESD – Hearing Aid, Air-Conduction, Prescription
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3300
- Specialty
- Ear, Nose, Throat
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
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| K232999 | Lyric4 Hearing AidESD · Traditional | Sonova AG | 04/11/2024SE |
| K130790 | LYRIC2ESD · Traditional | Phonak, LLC | 06/27/2013SE |
| K081136 | Lyric Hearing AidESD · Traditional | Insound Medical, Inc. | 05/08/2008SE |
| K021867 | Insound XT Series Hearing AidESD · Traditional | Insound Medical, Inc. | 11/19/2002SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | Siemens Hearing Instruments, Inc. | 04/24/2001SE |
| K984518 | Sonic Innovations Completely-In-The-Canal DSP Hearing Aid with Soft ShellESD · Traditional | Sonic Innovations, Inc. | 03/12/1999SE |
| K974751 | Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional | General Hearing Instruments, Inc. | 03/06/1998SE |
| K974242 | Argosy Programmable OnqueESD · Traditional | Argosy Electronics | 01/20/1998SE |
| K973880 | Sonix Hearing Aid Fitting and Programming SystemESD · Traditional | Sonix Technologies, Inc. | 01/12/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
More from Bernafon-Maico, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974340 | Unitron Model Sound F/Xp Programmable Mini BteESD · Traditional | 12/12/1997SE |
| K974339 | Unitron Model Sound F/Xd ProgrammableESD · Traditional | 12/12/1997SE |
| K974338 | Unitron Model F/X Programmable (Mini Bte)ESD · Traditional | 12/12/1997SE |
| K970692 | Unitron Model Sound F/X CicESD · Traditional | 05/08/1997SE |
| K970519 | Unitron Model Sound F/X Programmable Ite (Sf/X Programmable)ESD · Traditional | 04/24/1997SE |
| K964511 | Unitron Model Sound F/Xd +4 (Sound F/Xd +4)ESD · Traditional | 11/27/1996SE |
| K964510 | Unitron Model Icon Aohpd +4 (Icon Aohpd +4)ESD · Traditional | 11/27/1996SE |
| K964508 | Unitron Model Icon Aohp +4 (Icon Aohp +4)ESD · Traditional | 11/27/1996SE |
| K964504 | Unitron Model Icon Aohpl +4ESD · Traditional | 11/27/1996SE |
| K964502 | Unitron Model Sound F/Xp +4ESD · Traditional | 11/27/1996SE |
Questions and answers
When was Unitron Model Sound F/X +4 cleared by the FDA?
Unitron Model Sound F/X +4 (K964503) received a 510(k) decision of Substantially Equivalent on November 27, 1996, 19 days after the submission was received.
What is the product code of K964503?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.