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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 K946115
Device Name EK-VIEW(TM) ECG MANAGEMENT SYSTEM
Applicant
Apcot Medical Systems
3508 Market St.
Philadelphia,  PA  19104
Applicant Contact JOHN WONG
Correspondent
Apcot Medical Systems
3508 Market St.
Philadelphia,  PA  19104
Correspondent Contact JOHN WONG
Regulation Number870.1435
Classification Product Code
DXG  
Date Received12/15/1994
Decision Date 03/01/1995
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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