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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer, Ophthalmic
510(k) Number K940516
Device Name AUTO REFF-30
Applicant
Canon, Inc.
30-2 Shimomaruko 3-Chome
Ohta-Ku, Tokyo, Japan,  JP 146
Applicant Contact H. UCHII
Correspondent
Canon, Inc.
30-2 Shimomaruko 3-Chome
Ohta-Ku, Tokyo, Japan,  JP 146
Correspondent Contact H. UCHII
Regulation Number886.1760
Classification Product Code
HKO  
Date Received02/04/1994
Decision Date 07/12/1994
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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