Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K012416 |
Device Name |
CONFOSCAN 2 CONFOCAL MICROSCOPE |
Applicant |
NIDEK TECHNOLOGIES SRL |
21911 ERIE LN. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
CAROL PATTERSON |
Correspondent |
NIDEK TECHNOLOGIES SRL |
21911 ERIE LN. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
CAROL PATTERSON |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 07/30/2001 |
Decision Date | 10/26/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|