Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K110986 |
Device Name |
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 |
Applicant |
OPTOMED OY |
HALLITUSKATU 13-17 |
D 96 |
OULU,
FI
90100
|
|
Applicant Contact |
LAURA PIILA |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 04/08/2011 |
Decision Date | 05/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|