ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM


Device Classification Name

camera, ophthalmic, ac-powered

510(k) Number K022164
Device Name ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
Original Applicant
ZETA DEVELOPMENT LABORATORIES
4990 hillside circle
suite 400
el dorado hills, 
CA 
95762

Original Contact mark t fukuhara
Regulation Number 886.1120
Classification Product Code
HKI  
Date Received 07/03/2002
Decision Date 07/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No