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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 K911439
Device Name NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
Applicant
Canon USA, Inc.
30-2 Shimomaruko
3-Chome Ohta-Ku
Tokyo 146,  JP
Applicant Contact HIROHISA UCHII
Correspondent
Canon USA, Inc.
30-2 Shimomaruko
3-Chome Ohta-Ku
Tokyo 146,  JP
Correspondent Contact HIROHISA UCHII
Regulation Number886.1120
Classification Product Code
HKI  
Date Received04/02/1991
Decision Date 06/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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