Device Classification Name |
Chart, Visual Acuity
|
510(k) Number |
K863509 |
Device Name |
OPTEC 1000 DMV |
Applicant |
STEREO OPTICAL CO., INC. |
3539 NORTH KENTON |
CHICAGO,
IL
60641
|
|
Applicant Contact |
JOSEPH ANDERA |
Correspondent |
STEREO OPTICAL CO., INC. |
3539 NORTH KENTON |
CHICAGO,
IL
60641
|
|
Correspondent Contact |
JOSEPH ANDERA |
Regulation Number | 886.1150
|
Classification Product Code |
|
Date Received | 09/09/1986 |
Decision Date | 11/10/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|