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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 K894856
Device Name CARDIOPHONE
Applicant
Euro-American Marketing Group, Inc.
610 S. Albert
P.O. Box 823
Mount Prospect,  IL  60056
Applicant Contact BRENDA M BORDEWYK
Correspondent
Euro-American Marketing Group, Inc.
610 S. Albert
P.O. Box 823
Mount Prospect,  IL  60056
Correspondent Contact BRENDA M BORDEWYK
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/31/1989
Decision Date 01/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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