Device Classification Name |
tonometer, ac-powered
|
510(k) Number |
K013805 |
Device Name |
KOWA AUTOMATED TONOMETER KT-500 |
Applicant |
KOWA OPTIMED, INC. |
700 THIRTEENTH STREET, N.W. |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
FRANCES K WU |
Correspondent |
KOWA OPTIMED, INC. |
700 THIRTEENTH STREET, N.W. |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
FRANCES K WU |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 11/15/2001 |
Decision Date | 10/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|