Device Classification Name |
Audiometer
|
510(k) Number |
K983712 |
Device Name |
AMPLAID A311 SERIES |
Applicant |
AMPLIFON S.P.A. |
P.O. BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
AMPLIFON S.P.A. |
P.O. BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 10/21/1998 |
Decision Date | 01/12/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|