Faceplate, Custom In-The-Ear Hearing Aid, MCA10
FDA 510(k) K862768 · Maico Hearing Instruments, Inc.
510(k) numberK862768
Submission
- Device name
- Faceplate, Custom In-The-Ear Hearing Aid, MCA10
- Applicant
- Maico Hearing Instruments, Inc.
Minneapolis, MN, US - Received
- July 22, 1986
- Decision date
- August 13, 1986
- 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 |
|---|---|---|
| K960031 | Audioflex 120ESD · Traditional | 03/07/1996SE |
| K954054 | Maico Prodigy Cic SeriesESD · Traditional | 09/28/1995SE |
| K953161 | Maico MA630D Audiometer with Optional Reflex Decay & Eustachian Tube FunctionETY · Traditional | 07/24/1995SE |
| K950637 | Maico In-The-Ear Model RD-312 CicESD · Traditional | 03/21/1995SE |
| K946253 | Maico In-The-Ear Model RD 201ESD · Traditional | 01/30/1995SE |
| K931322 | KS 5 - Clinical AudiometerEWO · Traditional | 08/19/1994SE |
| K933291 | Maico Bte Model RD-111 and Ite Model RD-312 Hearing AidESD · Traditional | 08/23/1993SE |
| K930112 | Maico MA790 AudiometerEWO · Traditional | 08/05/1993SE |
| K926439 | MA25 - Portable Audiometer, ModificationEWO · Traditional | 08/05/1993SE |
| K931161 | Series Star 22 - Behind the Ear Hearing AidESD · Traditional | 06/01/1993SE |
Questions and answers
When was Faceplate, Custom In-The-Ear Hearing Aid, MCA10 cleared by the FDA?
Faceplate, Custom In-The-Ear Hearing Aid, MCA10 (K862768) received a 510(k) decision of Substantially Equivalent on August 13, 1986, 22 days after the submission was received.
What is the product code of K862768?
The FDA product code is LRB – Face Plate Hearing Aid, a Class I (low risk) device regulated under 21 CFR 874.3300.