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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 K862323
Device Name CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
Applicant
Canon USA, Inc.
One Jericho Plz.
Jericho,  NY  11753
Applicant Contact TAMADA
Correspondent
Canon USA, Inc.
One Jericho Plz.
Jericho,  NY  11753
Correspondent Contact TAMADA
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/19/1986
Decision Date 08/21/1986
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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