Device Classification Name |
hearing aid, group and auditory trainer
|
510(k) Number |
K922720 |
Device Name |
GROUP AUDITORY TRAINING SYSTEM |
Applicant |
PHONIC EAR, INC. |
3880 CYPRESS DR. |
PETALUMA,
CA
94954 -7600
|
|
Applicant Contact |
ROBERT L REINKE |
Correspondent |
PHONIC EAR, INC. |
3880 CYPRESS DR. |
PETALUMA,
CA
94954 -7600
|
|
Correspondent Contact |
ROBERT L REINKE |
Regulation Number | 874.3320
|
Classification Product Code |
|
Date Received | 06/05/1992 |
Decision Date | 08/24/1992 |
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
|
|
|