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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 K852971
Device Name #9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Applicant Contact CHARLES H SWANSON
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Correspondent Contact CHARLES H SWANSON
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/15/1985
Decision Date 10/22/1985
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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