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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 K903960
Device Name MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact TIERNEY NORSTED
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact TIERNEY NORSTED
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/28/1990
Decision Date 10/09/1990
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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