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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K033451
Device Name HEARTRAK SMART AT/HEARTRAK SMART2
Applicant
Universal Medical, Inc.
One Commerce Square
2005 Market St., Suite 2340
Philadelphia,  PA  19103
Applicant Contact DOUGLAS M LURIO
Correspondent
Universal Medical, Inc.
One Commerce Square
2005 Market St., Suite 2340
Philadelphia,  PA  19103
Correspondent Contact DOUGLAS M LURIO
Regulation Number870.2920
Classification Product Code
DXH  
Date Received10/30/2003
Decision Date 02/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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