Device Classification Name |
Tomography, Optical Coherence
|
510(k) Number |
K111157 |
Device Name |
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES |
Applicant |
CARL ZEISS MEDITEC INC |
5160 HACIENDA DR. |
DUBLIN,
CA
94568
|
|
Applicant Contact |
JUDITH A BRIMACOMBE |
Correspondent |
CARL ZEISS MEDITEC INC |
5160 HACIENDA DR. |
DUBLIN,
CA
94568
|
|
Correspondent Contact |
JUDITH A BRIMACOMBE |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 04/25/2011 |
Decision Date | 01/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|