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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K073625
Device Name MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
Applicant
GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact MARGARET MUCHA
Correspondent
GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact MARGARET MUCHA
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DHX   DQK  
Date Received12/26/2007
Decision Date 01/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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