Device Classification Name |
chart, visual acuity
|
510(k) Number |
K883337 |
Device Name |
PL 20/20 INFANT VISION TESTER |
Applicant |
OPTIMED TECHNOLOGIES, INC. |
515 E. 22ND TERRACE |
P.O. BOX 3663 |
LAWRENCE,
KS
66046
|
|
Applicant Contact |
BONNIE L MINKIN,PHD |
Correspondent |
OPTIMED TECHNOLOGIES, INC. |
515 E. 22ND TERRACE |
P.O. BOX 3663 |
LAWRENCE,
KS
66046
|
|
Correspondent Contact |
BONNIE L MINKIN,PHD |
Regulation Number | 886.1150
|
Classification Product Code |
|
Date Received | 08/09/1988 |
Decision Date | 10/31/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|