Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K123208 |
Device Name |
DIGITAL RETINAL CAMERA |
Applicant |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
4-1-17 HONGO |
BUNKYO-KU, TOKYO,
JP
113-0033
|
|
Applicant Contact |
IZUMI MARUO |
Correspondent |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
4-1-17 HONGO |
BUNKYO-KU, TOKYO,
JP
113-0033
|
|
Correspondent Contact |
IZUMI MARUO |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 10/12/2012 |
Decision Date | 03/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|