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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 K843021
Device Name CANON 60 FUNDUS CAMERA CF-60U
Applicant
Canon USA, Inc.
Melville,  NY  11747
Applicant Contact EIJI FUSE
Correspondent
Canon USA, Inc.
Melville,  NY  11747
Correspondent Contact EIJI FUSE
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/01/1984
Decision Date 10/05/1984
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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