Device Classification Name |
chart, visual acuity
|
510(k) Number |
K854983 |
Device Name |
OPTRONICS CONTRAST ACUITY TESTER |
Applicant |
OPTRONICS, INC. |
200 E. BUFFALO ST. |
ITHACA,
NY
14850
|
|
Applicant Contact |
PHILLIP LEMPERT |
Correspondent |
OPTRONICS, INC. |
200 E. BUFFALO ST. |
ITHACA,
NY
14850
|
|
Correspondent Contact |
PHILLIP LEMPERT |
Regulation Number | 886.1150
|
Classification Product Code |
|
Date Received | 12/12/1985 |
Decision Date | 02/04/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|