Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K133062 |
Device Name |
DISCOVERY SYSTEM |
Applicant |
INNOVATIVE VISUAL SYSTEMS |
386 NORTH YORK RD SUITE 209 |
ELMHURST,
IL
60126
|
|
Applicant Contact |
DONALD R SANDERS, M.D. PH.D |
Correspondent |
INNOVATIVE VISUAL SYSTEMS |
386 NORTH YORK RD SUITE 209 |
ELMHURST,
IL
60126
|
|
Correspondent Contact |
DONALD R SANDERS, M.D. PH.D |
Regulation Number | 886.1850
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/27/2013 |
Decision Date | 06/20/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|