Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K003236 |
Device Name |
RETINADX |
Applicant |
REGULATORY ASSOCIATES, INC. |
777 SOUTH WADESWORTH BLVD., |
BLDG. 2, SUITE 102 |
LAKEWOOD,
CO
80226
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
REGULATORY ASSOCIATES, INC. |
777 SOUTH WADESWORTH BLVD., |
BLDG. 2, SUITE 102 |
LAKEWOOD,
CO
80226
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 10/17/2000 |
Decision Date | 11/02/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|