Silver Rechargeable Module, Ite
FDA 510(k) K933045 · Electone, Inc.
510(k) numberK933045
Submission
- Device name
- Silver Rechargeable Module, Ite
- Applicant
- Electone, Inc.
Longwood, FL, US - Received
- April 28, 1993
- Decision date
- August 2, 1993
- 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 |
| 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 |
| 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 |
|---|---|---|
| K973266 | Z Deq-IiESD · Traditional | 09/23/1997SE |
| K961084 | Am 400ESD · Traditional | 04/18/1996SE |
| K955702 | Sonata U-01ESD · Traditional | 02/22/1996SE |
| K953050 | Z33ESD · Traditional | 08/22/1995SE |
| K953047 | Z20ESD · Traditional | 08/22/1995SE |
| K953054 | Am 260 OhmESD · Traditional | 08/15/1995SE |
| K953053 | Am 260 PPESD · Traditional | 08/15/1995SE |
| K953052 | Am 260 K-AmpESD · Traditional | 08/15/1995SE |
| K953051 | Z35ESD · Traditional | 08/15/1995SE |
| K953049 | Z24ESD · Traditional | 08/15/1995SE |
Questions and answers
When was Silver Rechargeable Module, Ite cleared by the FDA?
Silver Rechargeable Module, Ite (K933045) received a 510(k) decision of Substantially Equivalent on August 2, 1993, 96 days after the submission was received.
What is the product code of K933045?
The FDA product code is LRB – Face Plate Hearing Aid, a Class I (low risk) device regulated under 21 CFR 874.3300.