Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K152429 |
Device Name |
Slit Lamp Microscope |
Applicant |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. |
Zone A, 2nd Floor, No. 69, Lane |
1985, Chunshen Road Minhang District, |
SHANGHAI,
CN
200237
|
|
Applicant Contact |
WEIDA ZHAN |
Correspondent |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. |
Zone A, 2nd Floor, No. 69, Lane |
1985, Chunshen Road Minhang District, |
SHANGHAI,
CN
200237
|
|
Correspondent Contact |
WEIDA ZHAN |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 08/26/2015 |
Decision Date | 05/11/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|