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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Color Vision
510(k) Number K831074
Device Name OSCAR COLOR VISION TESTER
Applicant
Carl Zeiss, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Carl Zeiss, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.1170
Classification Product Code
HIT  
Date Received04/04/1983
Decision Date 04/28/1983
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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