Device Classification Name |
tester, color vision
|
510(k) Number |
K810700 |
Device Name |
CHROMOPS FM-100 COLOR VISION TESTER |
Applicant |
VISIDYNE CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
VISIDYNE CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1170
|
Classification Product Code |
|
Date Received | 03/16/1981 |
Decision Date | 04/10/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|