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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 K920790
Device Name MARQUETTE EAGLE MONITOR
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact GERRY BUSS
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact GERRY BUSS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received02/21/1992
Decision Date 04/19/1994
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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