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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 K861543
Device Name CARDIOMAX-II
Applicant
Columbus Instruments Intl. Corp.
P.O. Box 44049
Columbus,  OH  43204
Applicant Contact KAREN CARTER
Correspondent
Columbus Instruments Intl. Corp.
P.O. Box 44049
Columbus,  OH  43204
Correspondent Contact KAREN CARTER
Regulation Number870.1435
Classification Product Code
DXG  
Date Received04/24/1986
Decision Date 03/10/1987
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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