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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, Pre-Programmed, Single-Function
510(k) Number K863153
Device Name MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH
Applicant
Ocg Technology, Inc.
42 Executive Blvd.
Farmingdale,  NY  11735
Applicant Contact STEPHEN RAKOCZY
Correspondent
Ocg Technology, Inc.
42 Executive Blvd.
Farmingdale,  NY  11735
Correspondent Contact STEPHEN RAKOCZY
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/15/1986
Decision Date 01/06/1987
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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