EDINBURGH MASKER
FDA 510(k) clearance K800445 · decided 1980-03-12
Clearance details
- K-number
- K800445
- Device name
- EDINBURGH MASKER
- Applicant
- Foundation For Fluency, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-28
- Decision date
- 1980-03-12
- Days to decision
- 13 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
- Mchenry, IL, 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 |
| VOCALTECH VOCAL FEEDBACK DEVICE (K871590) | Vocaltech C/O Hogan & Hartson | 1987-10-06 |
Recalls involving this device
No recalls on record reference this clearance.