INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
FDA 510(k) clearance K961593 · decided 1996-11-07
Clearance details
- K-number
- K961593
- Device name
- INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
- Applicant
- Segi Hearing Aid Co.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-24
- Decision date
- 1996-11-07
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- LRB
- Device class
- 1
- Regulation number
- 874.3300
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FACEPLATE ASSEMBLY (K974219) | Finetone Hearing Instruments | 1998-02-20 |
| MODULE PROGRAM (K942722) | Electone, Inc. | 1994-09-06 |
| AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (K942236) | Audina Hearing Instrument | 1994-06-17 |
| ARTISAN PROGRAMMER & HEARING AID (K935048) | Telex Communications, Inc. | 1994-02-09 |
| GOLD AF MODULE, ITE (K933038) | Electone, Inc. | 1993-08-02 |
| GOLD CD MODULE, ITE (K933040) | Electone, Inc. | 1993-08-02 |
| SILVER RECHARGEABLE MODULE, ITE (K933045) | Electone, Inc. | 1993-08-02 |
| SILVER L MODULE, ITE (K933046) | Electone, Inc. | 1993-08-02 |
| SILVER PPP MODULE, ITE (K933043) | Electone, Inc. | 1993-08-02 |
| GOLD L MODULE, ITE (K933039) | Electone, Inc. | 1993-08-02 |
| GOLD K AMP, ITE (K933037) | Electone, Inc. | 1993-08-02 |
| SILVER LD MODULE, ITE (K933044) | Electone, Inc. | 1993-08-02 |
Recalls involving this device
No recalls on record reference this clearance.