KTH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, Anti-Stammering
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5840
- Medical specialty
- Ear, Nose, Throat
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| VOCALTECH VOCAL FEEDBACK DEVICE (K871590) | Vocaltech C/O Hogan & Hartson | 1987-10-06 |
| EDINBURGH MASKER (K800445) | Foundation For Fluency, Inc. | 1980-03-12 |
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Every clearance here is in the API, with alerts when new ones post.