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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 K970545
Device Name DASH 1000 PATIENT MONITOR
Applicant
Marquette Medical Systems, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact DIANNE SCHMITZ
Correspondent
Marquette Medical Systems, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact DIANNE SCHMITZ
Regulation Number870.1025
Classification Product Code
DSI  
Date Received02/12/1997
Decision Date 05/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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