Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K041546 |
Device Name |
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI |
Applicant |
CANON INC. |
ONE CANON PLAZA |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
SHEILA DRISCOLL |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
GLENN M LUCHEN |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 06/09/2004 |
Decision Date | 06/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|