Reliable
FDA 510(k) K834479 · Reliable Hearing Aide
510(k) numberK834479
Submission
- Device name
- Reliable
- Applicant
- Reliable Hearing Aide
- Received
- December 20, 1983
- Decision date
- July 11, 1984
- 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 |
Questions and answers
When was Reliable cleared by the FDA?
Reliable (K834479) received a 510(k) decision of Substantially Equivalent on July 11, 1984, 204 days after the submission was received.
What is the product code of K834479?
The FDA product code is LRB – Face Plate Hearing Aid, a Class I (low risk) device regulated under 21 CFR 874.3300.