EDINBURGH MASKER
Device Facts
| Record ID | K800445 |
|---|---|
| Device Name | EDINBURGH MASKER |
| Applicant | Foundation For Fluency, Inc. |
| Product Code | KTH · Ear, Nose, Throat |
| Decision Date | Mar 12, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.5840 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.
