Device Classification Name |
Device, Anti-Stammering
|
510(k) Number |
K942651 |
Device Name |
BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS |
Applicant |
CASA FUTURA TECHNOLOGIES |
18510 DECATUR DR. |
MONTE SERENO,
CA
95030 -3088
|
|
Applicant Contact |
THOMAS DAVID KEHOE |
Correspondent |
CASA FUTURA TECHNOLOGIES |
18510 DECATUR DR. |
MONTE SERENO,
CA
95030 -3088
|
|
Correspondent Contact |
THOMAS DAVID KEHOE |
Regulation Number | 874.5840
|
Classification Product Code |
|
Date Received | 06/03/1994 |
Decision Date | 10/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|