Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K162684 |
Device Name |
SL 220 |
Applicant |
Carl Zeiss Meditec AG |
Jena,
DE
07745
|
|
Applicant Contact |
Christian Muenster |
Correspondent |
Carl Zeiss Meditec, Inc. |
5160 Hacienda Drive |
Dublin,
CA
94568
|
|
Correspondent Contact |
Mandy Ambrecht |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 09/26/2016 |
Decision Date | 05/31/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|