Device Classification Name |
perimeter, automatic, ac-powered
|
510(k) Number |
K971156 |
Device Name |
KASHA VISUAL FIELD SYSTEM |
Applicant |
KASHA SOFTWARE, INC. |
1700 INTERFACE LAND #208 |
CHARLOTTE,
NC
28262
|
|
Correspondent |
KASHA SOFTWARE, INC. |
1700 INTERFACE LAND #208 |
CHARLOTTE,
NC
28262
|
|
Regulation Number | 886.1605
|
Classification Product Code |
|
Date Received | 03/28/1997 |
Decision Date | 05/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|