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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 K870527
Device Name CARDIOTEAM
Applicant
Cardiac Network, Inc.
100 Chopin Plz.
Suite 3110
Miami,  FL  33131
Applicant Contact INGRID FORTUN
Correspondent
Cardiac Network, Inc.
100 Chopin Plz.
Suite 3110
Miami,  FL  33131
Correspondent Contact INGRID FORTUN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/09/1987
Decision Date 04/20/1987
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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