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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 K844694
Device Name TITMUS VISION TESTER II
Applicant
Titmus Optical, Inc.
Petersburg,  VA  23803
Applicant Contact KINSEY
Correspondent
Titmus Optical, Inc.
Petersburg,  VA  23803
Correspondent Contact KINSEY
Regulation Number886.1170
Classification Product Code
HIT  
Date Received12/03/1984
Decision Date 01/22/1985
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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