Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K081858 |
Device Name |
RETCAM 3 OPHTHALMIC IMAGING SYSTEM |
Applicant |
CLARITY MEDICAL SYSTEMS |
5775 WEST LAS POSITAS BLVD. |
SUITE 200 |
PLEASANTON,
CA
94588 -4084
|
|
Applicant Contact |
GARY A SEEGER |
Correspondent |
CLARITY MEDICAL SYSTEMS |
5775 WEST LAS POSITAS BLVD. |
SUITE 200 |
PLEASANTON,
CA
94588 -4084
|
|
Correspondent Contact |
GARY A SEEGER |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 07/01/2008 |
Decision Date | 11/05/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|