MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)


Device Classification Name

camera, ophthalmic, ac-powered

510(k) Number K080180
Device Name MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
Applicant
OPTICAL IMAGING LTD.
555 thirteenth st. nw
washington, 
DC 
20004

Applicant Contact jonathan s kahan
Correspondent
OPTICAL IMAGING LTD.
555 thirteenth st. nw
washington, 
DC 
20004

Correspodent Contact jonathan s kahan
Regulation Number 886.1120
Classification Product Code
HKI  
Date Received 01/24/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No