Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K151394 |
Device Name |
Keeler Slit Lamp |
Applicant |
KEELER LIMITED |
CLEWER HILL ROAD |
WINDSOR,
GB
SL4 4AA
|
|
Applicant Contact |
IRINA PROUTSKI |
Correspondent |
Keeler Limited |
Clewer Hill Road |
Windsor,
GB
SL4 4AA
|
|
Correspondent Contact |
Irina Proutski |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 05/26/2015 |
Decision Date | 09/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|