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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 K032736
Device Name HEART 2006
Applicant
Aerotel Medical Systems (1998) , Ltd.
377 Route 17
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Aerotel Medical Systems (1998) , Ltd.
377 Route 17
Hasbrouck Heights,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/04/2003
Decision Date 10/03/2003
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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