Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K133476 |
Device Name |
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION |
Applicant |
CARL ZEISS MEDITEC AG |
5160 HACIENDA DRIVE |
DUBLIN,
CA
94568
|
|
Applicant Contact |
SARAH HARRINGTON |
Correspondent |
CARL ZEISS MEDITEC AG |
5160 HACIENDA DRIVE |
DUBLIN,
CA
94568
|
|
Correspondent Contact |
SARAH HARRINGTON |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 11/12/2013 |
Decision Date | 02/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|