LRB — Face Plate Hearing Aid Class I
FDA product code LRB covers "Face Plate Hearing Aid", a Class I medical device regulated under 21 CFR 874.3300. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LRB
- Device Class
- Class I
- Regulation Number
- 874.3300
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974219 | finetone hearing instruments | FACEPLATE ASSEMBLY | February 20, 1998 |
| K961593 | segi hearing aid | INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS | November 7, 1996 |
| K942722 | electone | MODULE PROGRAM | September 6, 1994 |
| K942236 | audina hearing instrument | AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) | June 17, 1994 |
| K935048 | telex communications | ARTISAN PROGRAMMER & HEARING AID | February 9, 1994 |
| K933038 | electone | GOLD AF MODULE, ITE | August 2, 1993 |
| K933044 | electone | SILVER LD MODULE, ITE | August 2, 1993 |
| K933037 | electone | GOLD K AMP, ITE | August 2, 1993 |
| K933040 | electone | GOLD CD MODULE, ITE | August 2, 1993 |
| K933045 | electone | SILVER RECHARGEABLE MODULE, ITE | August 2, 1993 |
| K933039 | electone | GOLD L MODULE, ITE | August 2, 1993 |
| K933043 | electone | SILVER PPP MODULE, ITE | August 2, 1993 |
| K933046 | electone | SILVER L MODULE, ITE | August 2, 1993 |
| K910900 | telex communications | FACEPLATE ITE HEARING AID MODEL TCA | May 30, 1991 |
| K910901 | telex communications | FACEPLATE ITE HEARING AID MODEL 28A | May 30, 1991 |
| K897023 | audina hearing instrument | OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID | March 16, 1990 |
| K896304 | olympia instruments | OLYMPIA FACEPLATE MODULE | January 26, 1990 |
| K873031 | starkey laboratories | STARKEY MODEL P1 MODULE | February 8, 1988 |
| K873300 | richards medical co | SERVICE MASTER (IMPULSE) | December 8, 1987 |
| K872645 | richards medical co | AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR | December 8, 1987 |