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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 K874017
Device Name MODIFIED RETINAL CAMERA MODEL 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 Received10/02/1987
Decision Date 11/02/1987
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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