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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K900540
Device Name TRAM PATIENT MONITOR
Applicant
MARQUETTE ELECTRONICS, INC.
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact SANDRA L SCHICK
Correspondent
MARQUETTE ELECTRONICS, INC.
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact SANDRA L SCHICK
Regulation Number870.1025
Classification Product Code
DSI  
Date Received02/05/1990
Decision Date 07/17/1990
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
Recalls CDRH Recalls
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