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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K050614
Device Name MUSE CARDIOLOGY INFORMATION SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact LISA M BAUMHARDT
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact LISA M BAUMHARDT
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/10/2005
Decision Date 04/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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