Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K170171 |
Device Name |
IOLMaster 700 |
Applicant |
Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 |
Jena,
DE
07445
|
|
Applicant Contact |
Christian Muenster |
Correspondent |
Biologics Consulting Group, Inc. |
400 N. Washington Street, Suite 100 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Rahul Ram |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 01/19/2017 |
Decision Date | 04/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|