Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K201122 |
Device Name |
Canon non-mydriatic retinal camera CR series |
Applicant |
Canon Inc. |
9-1, Imaikami-cho |
Nakahara-ku, Kawasaki,
JP
211-8501
|
|
Applicant Contact |
Akira Hirai |
Correspondent |
Canon Inc. |
9-1, Imaikami-cho |
Nakahara-ku, Kawasaki,
JP
211-8501
|
|
Correspondent Contact |
Akira Hirai |
Regulation Number | 886.1120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/27/2020 |
Decision Date | 07/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|