Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K131589 |
Device Name |
KEELER SLIT LAMP H-SERIES |
Applicant |
KEELER LTD. |
CLEWER HILL RD. |
WINDSOR, BERKSHIRE,
GB
SL4 4AA
|
|
Applicant Contact |
NICKIE POWER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 05/31/2013 |
Decision Date | 06/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|