Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K201325 |
Device Name |
Optomed Smartscope M5 with Optomed Smartscope FA |
Applicant |
Optomed Oyj |
Yrttipellontie 1 |
Oulu,
FI
90230
|
|
Applicant Contact |
Jyri Leskelä |
Correspondent |
Optomed Oyj |
Yrttipellontie 1 |
Oulu,
FI
90230
|
|
Correspondent Contact |
Jyri Leskelä |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 05/18/2020 |
Decision Date | 11/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|