Device Classification Name |
Perimeter, Automatic, Ac-Powered
|
510(k) Number |
K884867 |
Device Name |
OPTIFIELD I AND II AUTOMATED PERIMETERS |
Applicant |
OPTIMED, INC. |
100 HEGENBERGER RD. |
SUITE 210 |
OAKLAND,
CA
94621
|
|
Applicant Contact |
DOUGLAS DONALDSON |
Correspondent |
OPTIMED, INC. |
100 HEGENBERGER RD. |
SUITE 210 |
OAKLAND,
CA
94621
|
|
Correspondent Contact |
DOUGLAS DONALDSON |
Regulation Number | 886.1605
|
Classification Product Code |
|
Date Received | 11/21/1988 |
Decision Date | 03/09/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|