Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K923958 |
Device Name |
CHROMOS IMAGER |
Applicant |
CHROMOS IMAGING, INC. |
5025 STAGE RD. |
SUITE 236 |
MEMPHIS,
TN
38128
|
|
Applicant Contact |
STEVEN E LUSTY |
Correspondent |
CHROMOS IMAGING, INC. |
5025 STAGE RD. |
SUITE 236 |
MEMPHIS,
TN
38128
|
|
Correspondent Contact |
STEVEN E LUSTY |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 08/06/1992 |
Decision Date | 03/04/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|