CR-1


Device Classification Name

camera, ophthalmic, ac-powered

510(k) Number K080883
Device Name CR-1
Applicant
CANON, INC.
one canon plaza
lake success, 
NY 
11042 -1198

Applicant Contact sheila driscoll
Regulation Number 886.1120
Classification Product Code
HKI  
Date Received 03/31/2008
Decision Date 04/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No