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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K896017
Device Name THE OPHTHIMUS SYSTEM
Applicant
Hightech Vision
583 Mountain Ave.
North Caldwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Hightech Vision
583 Mountain Ave.
North Caldwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/16/1989
Decision Date 10/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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