VOCALTECH VOCAL FEEDBACK DEVICE
FDA 510(k) clearance K871590 · decided 1987-10-06
Clearance details
- K-number
- K871590
- Device name
- VOCALTECH VOCAL FEEDBACK DEVICE
- Applicant
- Vocaltech C/O Hogan & Hartson
- Decision
- Substantially Equivalent
- Date received
- 1987-04-24
- Decision date
- 1987-10-06
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- KTH
- Device class
- 1
- Regulation number
- 874.5840
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Washington, D.C., DC, 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 |
|---|---|---|
| SUSTAINED PHONATION (K962961) | Surface Mount Technology, Inc. | 1996-09-09 |
| BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS (K942651) | Casa Futura Technologies | 1995-10-19 |
| EDINBURGH MASKER (K800445) | Foundation For Fluency, Inc. | 1980-03-12 |
Recalls involving this device
No recalls on record reference this clearance.