Faceplate Assembly
FDA 510(k) K974219 · Finetone Hearing Instruments
510(k) numberK974219
Submission
- Device name
- Faceplate Assembly
- Applicant
- Finetone Hearing Instruments
Scarborough, ME, US - Received
- November 10, 1997
- Decision date
- February 20, 1998
- 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 |
|---|---|---|---|
| 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 |
| K933039 | Gold L Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
More from Electone, Inc.
Questions and answers
When was Faceplate Assembly cleared by the FDA?
Faceplate Assembly (K974219) received a 510(k) decision of Substantially Equivalent on February 20, 1998, 102 days after the submission was received.
What is the product code of K974219?
The FDA product code is LRB – Face Plate Hearing Aid, a Class I (low risk) device regulated under 21 CFR 874.3300.