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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 K864583
Device Name CARDIAC PERFORMANCE MONITOR
Applicant
Vascular Technology Incorporated
Medical Device Consultants,Inc
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact JAMES R VEALE
Correspondent
Vascular Technology Incorporated
Medical Device Consultants,Inc
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact JAMES R VEALE
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/20/1986
Decision Date 05/11/1987
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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