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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 K014108
Device Name MAC 5000 ECG ANALYSIS SYSTEM
Applicant
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact LISA LEE MICHELS
Correspondent
General Electric Medical Systems Information Techn
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact LISA LEE MICHELS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/13/2001
Decision Date 01/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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