CIRRUS PHOTO


Device Classification Name

tomography, optical coherence

510(k) Number K112184
Device Name CIRRUS PHOTO
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  
Subsequent Product Code
HKI  
Date Received 07/28/2011
Decision Date 06/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No