Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K140451 |
Device Name |
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) |
Applicant |
KEELER LIMITED |
456 PARKWAY |
BROOMALL,
PA
19008
|
|
Applicant Contact |
EUGENE VAN ARSDALE |
Correspondent |
KEELER LIMITED |
456 PARKWAY |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
EUGENE VAN ARSDALE |
Regulation Number | 886.1850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/24/2014 |
Decision Date | 07/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|