Device Classification Name |
Tonometer, Manual
|
510(k) Number |
K180839 |
Device Name |
AT 030 |
Applicant |
Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 |
Jena,
DE
07745
|
|
Applicant Contact |
Christian Muenster |
Correspondent |
Biologics Consulting |
1555 King Street, Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Becky Ditty |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 03/30/2018 |
Decision Date | 06/07/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|