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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 K072502
Device Name MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 INNAVATION DR.
wauwatosa,  WI  53226
Applicant Contact patricia taige
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 INNAVATION DR.
wauwatosa,  WI  53226
Correspondent Contact patricia taige
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/06/2007
Decision Date 11/19/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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