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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 K072385
Device Name HEARTEVENT, MODEL AT
Applicant
Diagnostic Devices Pty, Ltd.
Suite 405 Office Tower
Westfield Eastgardens
Eastgardens,  AU 2036
Applicant Contact HARRY PLATT
Correspondent
Diagnostic Devices Pty, Ltd.
Suite 405 Office Tower
Westfield Eastgardens
Eastgardens,  AU 2036
Correspondent Contact HARRY PLATT
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/24/2007
Decision Date 01/11/2008
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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