Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K153545 |
Device Name |
Portable Slit Lamp |
Applicant |
SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. |
NO.29, Jiuyuan Road, Qingpu Industrial Park, Shanghai, |
Shanghai,
CN
201700
|
|
Applicant Contact |
Johnny Hu |
Correspondent |
SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. |
NO.29, Jiuyuan Road, Qingpu Industrial Park, Shanghai , |
Shanghai,
CN
201700
|
|
Correspondent Contact |
Johnny Hu |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 12/11/2015 |
Decision Date | 06/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|