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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K031629
Device Name CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
Applicant
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Applicant Contact SHEILA DRISCOLL
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact KENT DONOHUE
Regulation Number886.1120
Classification Product Code
HKI  
Date Received05/27/2003
Decision Date 06/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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