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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hospital Cardiac Telemetry
510(k) Number K934913
Device Name HEARTRAC ECG MONITORING SYSTEM
Applicant
Cardiac Telecom Corp.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Cardiac Telecom Corp.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number870.1025
Classification Product Code
QYW  
Subsequent Product Code
DSI  
Date Received10/15/1993
Decision Date 06/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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