Faceplate Ite Hearing Aid Model Tca
FDA 510(k) K910900 · Telex Communications, Inc.
510(k) numberK910900
Submission
- Device name
- Faceplate Ite Hearing Aid Model Tca
- Applicant
- Telex Communications, Inc.
Minneapolis, MN, US - Received
- March 5, 1991
- Decision date
- May 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K942236 | Audina Prewires (Faceplate Hearing Aid Series)LRB · Traditional | Audina Hearing Instrument | 06/17/1994SE |
| 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 |
More from Electone, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984243 | Telex Tinnitus-CompanionKLW · Traditional | 01/21/1999SE |
| K982683 | Telex Select 1-40 with Adaptive CompressionEPF · Traditional | 10/06/1998SE |
| K964639 | Telex In-The-Ear Custom Hearing Aid with Threshold Compression-IiESD · Traditional | 01/21/1997SE |
| K963915 | Telex In-The-Ear Custom Hearing Aid with Threshold CompressionESD · Traditional | 11/08/1996SE |
| K961143 | Telex Select 2-40 with Adaptive Compression S2-40ESD · Traditional | 05/07/1996SE |
| K954579 | Telex 349 Multi Cros W/Adapive CompressionESD · Traditional | 12/08/1995SE |
| K943961 | The Model Acappella in the Ear Hearing AidESD · Traditional | 05/15/1995SE |
| K935048 | Artisan Programmer & Hearing AidLRB · Traditional | 02/09/1994SE |
| K935366 | Binaural Hearing AidESD · Traditional | 01/13/1994SE |
| K933579 | Memorex Artisan System/Artisan Programmer and Custom Hearing AidESD · Traditional | 08/23/1993SE |
Questions and answers
When was Faceplate Ite Hearing Aid Model Tca cleared by the FDA?
Faceplate Ite Hearing Aid Model Tca (K910900) received a 510(k) decision of Substantially Equivalent on May 30, 1991, 86 days after the submission was received.
What is the product code of K910900?
The FDA product code is LRB – Face Plate Hearing Aid, a Class I (low risk) device regulated under 21 CFR 874.3300.