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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 K001359
Device Name DASH 3000/4000 PATIENT MONITOR
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact DAVID WAHLIG
Correspondent
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact DAVID WAHLIG
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/28/2000
Decision Date 07/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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