KTH — Device, Anti-Stammering Class I
FDA product code KTH covers "Device, Anti-Stammering", a Class I medical device regulated under 21 CFR 874.5840. Submissions are reviewed by the Ear, Nose, Throat panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KTH
- Device Class
- Class I
- Regulation Number
- 874.5840
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962961 | surface mount technology | SUSTAINED PHONATION | September 9, 1996 |
| K942651 | casa futura technologies | BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS | October 19, 1995 |
| K871590 | vocaltech c/o hogan and hartson | VOCALTECH VOCAL FEEDBACK DEVICE | October 6, 1987 |
| K800445 | foundation for fluency | EDINBURGH MASKER | March 12, 1980 |