VISUCAM


Device Classification Name

device, storage, images, ophthalmic

510(k) Number K021787
Device Name VISUCAM
Original Applicant
CARL ZEISS OPHTHALMIC SYSTEMS, INC.
555 thireenth street, n.w.
washington, 
DC 
20004 -1109

Original Contact dionne n labatore
Regulation Number 892.2010
Classification Product Code
NFF  
Subsequent Product Code
NFG  
Date Received 05/30/2002
Decision Date 06/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No