FDA Product Code
FDA Product Code KTH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.5840
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K962961 | SUSTAINED PHONATION | Surface Mount Technology, Inc. | 1996-09-09 | Traditional | PDF ↗ |
| K942651 | BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS | Casa Futura Technologies | 1995-10-19 | Traditional | PDF ↗ |
| K871590 | VOCALTECH VOCAL FEEDBACK DEVICE | Vocaltech C/O Hogan & Hartson | 1987-10-06 | Traditional | PDF ↗ |
| K800445 | EDINBURGH MASKER | Foundation For Fluency, Inc. | 1980-03-12 | Traditional | PDF ↗ |
Product code KTH · Class I · Ear, Nose, Throat. Data: openFDA.