Audina Prewires (Faceplate Hearing Aid Series)
FDA 510(k) K942236 · Audina Hearing Instrument
510(k) numberK942236
Submission
- Device name
- Audina Prewires (Faceplate Hearing Aid Series)
- Applicant
- Audina Hearing Instrument
Casselberry, FL, US - Received
- May 9, 1994
- Decision date
- June 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRB – Face Plate Hearing Aid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3300
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LRB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974219 | Faceplate AssemblyLRB · Traditional | Finetone Hearing Instruments | 02/20/1998SE |
| K961593 | Intrastar Pre-Wired Faceplate for In-The-Ear Hearing AidsLRB · Traditional | Segi Hearing Aid Co. | 11/07/1996SE |
| K942722 | Module ProgramLRB · Traditional | Electone, Inc. | 09/06/1994SE |
| K935048 | Artisan Programmer & Hearing AidLRB · Traditional | Telex Communications, Inc. | 02/09/1994SE |
| K933046 | Silver L Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933045 | Silver Rechargeable Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933044 | Silver LD Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933043 | Silver PPP Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933040 | Gold CD Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933039 | Gold L Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
More from Electone, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964816 | Audina 153 Behind the Ear and Audina 158 Behind the EarESD · Traditional | 01/17/1997SE |
| K953960 | Hearing Aid (All-In-The-Ear)ESD · Traditional | 09/12/1995SE |
| K936190 | Behind the Ear Hearing AidESD · Traditional | 04/04/1994SE |
| K930271 | Behind-The-Ear Hearing AidESD · Traditional | 03/18/1993SE |
| K897024 | Model Audina Ite Heating AidESD · Traditional | 04/18/1990SE |
| K897023 | Oversight Program for In-Office Assembly, HRNG AidLRB · Traditional | 03/16/1990SE |
| K820833 | Audicraft Vip Hearing AidESD · Traditional | 04/09/1982SE |
Questions and answers
When was Audina Prewires (Faceplate Hearing Aid Series) cleared by the FDA?
Audina Prewires (Faceplate Hearing Aid Series) (K942236) received a 510(k) decision of Substantially Equivalent on June 17, 1994, 39 days after the submission was received.
What is the product code of K942236?
The FDA product code is LRB – Face Plate Hearing Aid, a Class I (low risk) device regulated under 21 CFR 874.3300.