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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 K895474
Device Name NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
Applicant
CANON U.S.A., INC.
30-2 SHIMOMARUKO
3-CHOME OHTA-KU
TOKYO 146,  JP
Applicant Contact HIROHISA UCHII
Correspondent
CANON U.S.A., INC.
30-2 SHIMOMARUKO
3-CHOME OHTA-KU
TOKYO 146,  JP
Correspondent Contact HIROHISA UCHII
Regulation Number886.1120
Classification Product Code
HKI  
Date Received09/11/1989
Decision Date 10/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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