Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K853895 |
Device Name |
AUDTEX 85 |
Applicant |
CAMI, INC. |
P.O. BOX 758 |
LEAGUE CITY,
TX
77573
|
|
Applicant Contact |
ROGER B MICHAUD |
Correspondent |
CAMI, INC. |
P.O. BOX 758 |
LEAGUE CITY,
TX
77573
|
|
Correspondent Contact |
ROGER B MICHAUD |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 09/20/1985 |
Decision Date | 12/20/1985 |
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
|
|
|