Device Classification Name |
Hearing Aid, Group And Auditory Trainer
|
510(k) Number |
K771671 |
Device Name |
AUDITORY TRAINER |
Applicant |
ACCUTONE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ACCUTONE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.3320
|
Classification Product Code |
|
Date Received | 09/01/1977 |
Decision Date | 09/12/1977 |
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
|
|
|