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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 K110132
Device Name MUSE CARDIOLOGY INFORMATION SYSTEM
Applicant
Ge Medical Systems Information Technologies, Inc.
9900 W Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact KRISTIN PABST
Correspondent
Ge Medical Systems Information Technologies, Inc.
9900 W Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact KRISTIN PABST
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/18/2011
Decision Date 05/25/2011
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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