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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 K071130
Device Name HEARTRAK AF
Applicant
Universal Medical, Inc.
275 Phillips Blvd.
Ewing,  NJ  08618
Applicant Contact STEVEN ADAMSKY
Correspondent
Universal Medical, Inc.
275 Phillips Blvd.
Ewing,  NJ  08618
Correspondent Contact STEVEN ADAMSKY
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/23/2007
Decision Date 05/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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