CIRRUS RD-OCT WITH RETINAL NERVE FIBER LAYER, OPTIC DISC, MACULAR, GANGLION CELL AND ASIAN NORMATIVE DATABASES


Device Classification Name

tomography, optical coherence

510(k) Number K111157
Device Name CIRRUS RD-OCT WITH RETINAL NERVE FIBER LAYER, OPTIC DISC, MACULAR, GANGLION CELL AND ASIAN 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

Correspodent Contact judith a brimacombe
Regulation Number 886.1570
Classification Product Code
OBO  
Date Received 04/25/2011
Decision Date 01/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No